<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04462367</url>
  </required_header>
  <id_info>
    <org_study_id>NCOVIP</org_study_id>
    <nct_id>NCT04462367</nct_id>
  </id_info>
  <brief_title>Northeast COVID-19 and Pregnancy Study Group</brief_title>
  <acronym>NCOVIP</acronym>
  <official_title>Clinical and Laboratory Predictors of COVID-19 Progression and Maternal and Perinatal Outcomes in Infected Pregnant and Postpartum Women in Six Reference Centers in the Northeast of Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Materno Infantil Prof. Fernando Figueira</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Materno Infantil Prof. Fernando Figueira</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective and retrospective cohort study. The objective will to determine the frequency&#xD;
      of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, to evaluate&#xD;
      clinical and laboratory predictors of COVID-19 progression and to determine the factors&#xD;
      associated with adverse maternal and perinatal outcomes in healthcare centers in two states&#xD;
      of Northeast Brazil.The study will be conducted including pregnant and postpartum women with&#xD;
      clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the&#xD;
      Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of&#xD;
      COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy&#xD;
      ward, obstetric intensive care unit and rooming-in ward will be included. The data will be&#xD;
      collected in specific forms. The exams will be carried out by trained professionals within&#xD;
      each institution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General Objective: To determine the frequency of COVID-19 in pregnant and postpartum women&#xD;
      admitted with flu syndrome, to evaluate the clinical and laboratory predictors of COVID-19&#xD;
      progression and to identify the factors associated with adverse maternal and perinatal /&#xD;
      neonatal outcomes in six reference centers in the Northeast of Brazil.&#xD;
&#xD;
      Specific objectives&#xD;
&#xD;
      In pregnant and postpartum women admitted to the four institutions involved with flu-like&#xD;
      symptoms or SARS:&#xD;
&#xD;
        1. To describe the biological characteristics (maternal age and pre-pregnancy maternal&#xD;
           weight, maternal height, pre-gestational body mass index - BMI and pre-gestational&#xD;
           nutritional classification), sociodemographic characteristics (color, number of people&#xD;
           living in the household, per capita family income, education, occupation, occupation,&#xD;
           marital status, origin and religion), habits (smoking, drinking and use of illicit&#xD;
           drugs), obstetric characteristics (number of pregnancies, parity, previous vaginal&#xD;
           delivery and previous cesarean, previous abortions, number live children, entry into the&#xD;
           study and number of prenatal consultations) and the service of origin (IMIP, HDM, ISEA&#xD;
           or MFD);&#xD;
&#xD;
        2. To describe the clinical characteristics (gestational age or postpartum days at the&#xD;
           beginning of signs and symptoms, duration of symptoms, isolation, social distance and&#xD;
           quarantine before signs and symptoms, need for hospitalization due to infection and / or&#xD;
           complications, day of hospitalization due to flu-like syndrome and / or complications,&#xD;
           length of hospital stay due to flu-like syndrome and / or complications and the main&#xD;
           related signs and symptoms and days of onset - dry or productive cough, runny nose, sore&#xD;
           throat, body pain, abdominal pain , chest pain, headache, smell and taste changes,&#xD;
           dyspnoea, subfebrile state and fever, diarrhea, asthenia, saturation level, axillary&#xD;
           temperature and mild / moderate signs and symptoms);&#xD;
&#xD;
        3. To determine the frequency of COVID-19 infection according to the results of diagnostic&#xD;
           tests (rapid test, RT-PCR and serology) applied during hospitalization;&#xD;
&#xD;
        4. To describe the maternal laboratory parameters at the time of the diagnosis of influenza&#xD;
           syndrome and the worst laboratory tests (result of RT-PCR for COVID-19, result of viral&#xD;
           panel and type of virus, serology for COVID-19 - IgM, IgA and serial IgG, inflammatory&#xD;
           cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4,&#xD;
           IL-1β, IL-9, IL-15, Interferon - IFN-γ, tumor necrosis factor - TNF-α, blood count,&#xD;
           coagulogram, urea, creatinine, transaminases - ALT, AST, erythrocyte sedimentation rate&#xD;
           - VSH, C reactive protein - CRP), D-dimer, lactic dehydrogenase - LDH, alkaline&#xD;
           phosphatase, bilirubins, ferritin, troponin, blood culture, urine culture, blood gas&#xD;
           analysis and day of all tests);&#xD;
&#xD;
        5. To describe the radiological findings (chest X-rays, computed tomography), the pulmonal&#xD;
           ultrasonography and day of exam alteration and normalization;&#xD;
&#xD;
        6. To describe the therapeutic modalities performed (oxygen therapy - nasal catheter or&#xD;
           Venturi with its maximum flows, use of prone in spontaneous ventilation and / or&#xD;
           mechanical ventilation, use of mechanical ventilation, use of neuromuscular blocker, use&#xD;
           of extracorporeal membrane oxygenation - ECMO, use of: antibiotics, azithromycin,&#xD;
           hydroxychloroquine / chloroquine, antiparasitic drugs such as ivermectin, anticoagulant&#xD;
           and / or antiretroviral, pulse therapy, convalescent plasma, need for renal replacement&#xD;
           therapy, blood products and others, start day and duration of all therapeutic modalities&#xD;
           performed);&#xD;
&#xD;
        7. To describe the characteristics of obstetric ultrasound (tachycardia, frequency of&#xD;
           diagnosis of fetal growth restriction, fetus small for gestational age - SGA, changes in&#xD;
           amniotic fluid and fetal morphological changes) performed during the course of infection&#xD;
           and post-infection follow-up;&#xD;
&#xD;
        8. To describe the doppler velocimetric parameters of the uterine and fetal circulation&#xD;
           (pulsatility index of the middle uterine arteries, the middle fetal cerebral artery -&#xD;
           MCA, the umbilical artery, the venous duct, the frequency of changes in the doppler&#xD;
           velocimetry of all the vessels studied and the speed of the systolic peak in MCA) during&#xD;
           infection and in the post-infection follow-up;&#xD;
&#xD;
        9. To describe invasive intrauterine diagnostic procedures (amniocentesis), gestational age&#xD;
           at which amniocentesis was performed, indications, results of the RT-PCR test for&#xD;
           COVID-19, results of the TORCHS survey, results of the karyotype and results of the&#xD;
           inflammatory cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13,&#xD;
           IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN- γ, tumor necrosis factor - TNF-α;&#xD;
&#xD;
       10. To determine comorbidities / complications associated with pregnancy or the puerperium&#xD;
           (need for hospitalization due to obstetric causes, length of hospital stay, obesity,&#xD;
           multiple pregnancy, hypertensive syndromes, diabetes - clinical or gestational, heart&#xD;
           disease, chronic obstructive pulmonary disease, bronchial asthma, cerebrovascular&#xD;
           disease, renal failure, immunosuppression, severe acute respiratory syndrome - SARS,&#xD;
           premature rupture of membranes, premature labor, placenta praevia, urinary tract&#xD;
           infection, pneumonia, sepsis, septic shock, abortion, abruptio placenta, postpartum&#xD;
           hemorrhage, infection of surgical site, endometritis, peritonitis, thromboembolic&#xD;
           events, need for postpartum hysterectomy, need for other surgeries after delivery and&#xD;
           tubal ligation, maternal near miss criteria);&#xD;
&#xD;
       11. To describe the delivery outcomes (type of delivery - vaginal, spontaneous or operative,&#xD;
           or cesarean section, indication for cesarean section, indication for labor induction,&#xD;
           method of labor induction, duration of induction, gestational age at delivery, use of&#xD;
           labor analgesia, type of anesthesia for cesarean section);&#xD;
&#xD;
       12. To describe prenatal interventions (antenatal corticosteroid therapy - number of doses,&#xD;
           use of magnesium sulfate and prophylactic antibiotic therapy);&#xD;
&#xD;
       13. To describe the final maternal outcome (discharge of the pregnant woman, discharge of&#xD;
           the postpartum woman, death of the pregnant woman and death of the postpartum woman);&#xD;
&#xD;
       14. To describe perinatal and neonatal outcomes (fetal death, perinatal death, birth weight,&#xD;
           birth weight adequacy - SGA, AGA, LGA, Apgar scores in the first and fifth minutes, need&#xD;
           for neonatal resuscitation, ICU admission, need for assisted mechanical ventilation,&#xD;
           oxygen therapy, oxygen therapy modalities, hypothermia, hypoglycemia, polycythemia,&#xD;
           anemia, neonatal infection, chorioamnionitis, type of respiratory distress,&#xD;
           breastfeeding, neonatal congenital infections (TORCHS), congenital malformation, other&#xD;
           neonatal morbidities, neonatal near miss, neonatal death, days of life of neonatal death&#xD;
           and length of hospital stay and in neonatal ICU);&#xD;
&#xD;
       15. To determine the procedures in neonatal care in the delivery room (cord clamping - early&#xD;
           or opportune, skin-to-skin contact, breastfeeding in the delivery room) and,&#xD;
           subsequently, rooming-in or admission to a neonatal ICU / nursing unit;&#xD;
&#xD;
       16. To describe the neonatal laboratory parameters of the suspected diagnosis or&#xD;
           confirmation of COVID-19 and the worst test results (days of life of the newborn's&#xD;
           suspected diagnosis, result of rapid neonate test, RT-PCR for COVID-19 in nasopharyngeal&#xD;
           swab , result of viral panel and virus type, serology for COVID-19 - IgM, IgA and IgG&#xD;
           serial, inflammatory cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL -12,&#xD;
           IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ, tumor necrosis factor -&#xD;
           TNF-α, blood count, coagulogram, urea, creatinine, transaminases - ALT, AST, erythrocyte&#xD;
           sedimentation rate - VSH, C-reactive protein - CRP), D-dimer, lactic dehydrogenase -&#xD;
           LDH, alkaline phosphatase, bilirubins, ferritin, troponin, blood culture, urine culture,&#xD;
           blood gas analysis and day of all tests);&#xD;
&#xD;
       17. To describe the laboratory parameters in the placenta (result of RT-PCR / viral panel by&#xD;
           swab and anatomopathological study) and in cord blood (RT-PCR);&#xD;
&#xD;
       18. To determine the frequency of vertical transmission and the factors associated with a&#xD;
           higher risk of its occurrence (gestational age at infection, severity of infection,&#xD;
           laboratory markers, type of delivery, labor, cord clamping practice, placental findings,&#xD;
           maternal interleukins);&#xD;
&#xD;
       19. To describe the laboratory parameters in breast milk (result of RT-PCR / viral panel);&#xD;
&#xD;
       20. To describe the neonatal imaging exams (chest X-rays, computed tomography and day of&#xD;
           exam changes and normalization);&#xD;
&#xD;
       21. To determine the association of biological, sociodemographic, obstetric variables,&#xD;
           habits, clinical, maternal laboratory parameters in the diagnosis and the worst result,&#xD;
           radiological findings, therapeutic modalities, ultrasound and doppler velocimetric&#xD;
           characteristics, invasive procedures, comorbidities / complications and characteristics&#xD;
           of childbirth with adverse maternal outcome (maternal near miss and maternal death).&#xD;
&#xD;
       22. To determine the association of biological, sociodemographic, obstetric variables,&#xD;
           habits, clinical, maternal laboratory parameters in the diagnosis and the worst result,&#xD;
           radiological findings, therapeutic modalities, ultrasound and doppler velocimetric&#xD;
           characteristics, invasive procedures, comorbidities / complications, delivery results,&#xD;
           prenatal interventions, final pregnancy outcome, delivery room procedures, neonatal care&#xD;
           and neonatal laboratory parameters, placenta, amniotic fluid and breast milk with&#xD;
           adverse perinatal / neonatal outcome (neonatal near miss and fetal / neonatal death);&#xD;
&#xD;
       23. To analyze maternal and perinatal mortality according to gestational age at the onset of&#xD;
           symptoms (Kaplan-Meier survival curve);&#xD;
&#xD;
       24. To compare data from two states in Northeast Brazil with official general data in the&#xD;
           country according to the Ministry of Health for the pregnancy-puerperal cycle.&#xD;
&#xD;
       25. In a subset of women routinely assessed on admission through the rapid test (ISEA and&#xD;
           Unimed-João Pessoa), to determine the frequency of positive rapid test, positive RT-PCR,&#xD;
           associated symptoms, asymptomatic carriers and to compare maternal and perinatal&#xD;
           outcomes according to test results.&#xD;
&#xD;
       26. To carry out long-term monitoring of women and babies included in the cohort in 2020, to&#xD;
           detect recurrence of symptoms, frequency of reinfection, evolution of laboratory&#xD;
           parameters (repetition of RT-PCR and serology) and monitoring of growth and development&#xD;
           in the cohort of children aged six months, 12 and 24 months.&#xD;
&#xD;
      Methods: A prospective and retrospective cohort study will be conducted including pregnant&#xD;
      and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six&#xD;
      healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with&#xD;
      clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity&#xD;
      triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be&#xD;
      included. The data will be collected in specific forms. The exams will be carried out by&#xD;
      trained professionals within each institution. A database will be created on the RedCap&#xD;
      platform. For the association of dependent variables (maternal mortality / near miss and&#xD;
      unfavorable perinatal outcomes) with independent variables (biological, sociodemographic&#xD;
      characteristics, history, clinical characteristics, ultrasound modifications, doppler&#xD;
      velocimetric and laboratory tests, chi-square tests will be used and Fisher's exact, when&#xD;
      pertinent, with a significance level of 5%. The relative risk and its 95% confidence interval&#xD;
      will also be calculated to determine the strength of association between the variables.&#xD;
      outcomes, Student t or Mann-Whitney tests will be adopted. A multivariate analysis will be&#xD;
      performed to determine the variables that will actually remain associated, in addition, a&#xD;
      Kaplan-Meier survival curve will be constructed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Near miss maternal:</measure>
    <time_frame>42 days</time_frame>
    <description>Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal death</measure>
    <time_frame>42 days</time_frame>
    <description>It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Near miss neonate</measure>
    <time_frame>7 days</time_frame>
    <description>It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar &lt;7 in the 5th minute, birth weight &lt;1,750 grams or gestational age &lt;33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neonatal death</measure>
    <time_frame>27 days</time_frame>
    <description>Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early neonatal death</measure>
    <time_frame>7 days</time_frame>
    <description>Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fetal death</measure>
    <time_frame>1 hour</time_frame>
    <description>Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perinatal death</measure>
    <time_frame>7 days</time_frame>
    <description>Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal age</measure>
    <time_frame>1 hour</time_frame>
    <description>Calculated based on the date of birth recorded in the medical record, hospital identification data, or according to the patient's information, in full years. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal pre-pregnancy weight</measure>
    <time_frame>1 hour</time_frame>
    <description>maternal weight before pregnancy, in kilogram (kg), according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal height</measure>
    <time_frame>1 hour</time_frame>
    <description>expressed, in meters, according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-gestational nutritional classification</measure>
    <time_frame>1 hour</time_frame>
    <description>classified according to pre-gestational BMI: low weight grade III (≤ 16.00), low weight grade II (≥ 16.00 to &lt;16.99), low weight grade I (≥ 17 , 00 to &lt;18.49), ideal weight (≥ 18.50 to &lt;24.99), overweight (≥ 25.00 to &lt;29.99), grade I obesity (≥ 30.00 to &lt;34.99) , grade II obesity (≥35.00 to &lt;39.99) and grade III obesity (≥ 40.00).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-gestational body mass index (BMI)</measure>
    <time_frame>1 hour</time_frame>
    <description>expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal color</measure>
    <time_frame>1 hour</time_frame>
    <description>according to the patient's self-declaration and collected according to information and / or recorded in the medical record or prenatal card in black, white, brown, yellow and indigenous.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of people living in the household</measure>
    <time_frame>1 hour</time_frame>
    <description>defined as the number of people, regardless of age, living in the same household, collected according to the patient's information. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family income per capita</measure>
    <time_frame>1 hour</time_frame>
    <description>collected according to the patient's information as the sum of the monthly income of all members living in the household, including benefits from social programs and informal income. Categorized in: up to 1 minimum wage; 1 to 2 minimum wages; 3 to 5 minimum wages; more than 5 minimum wages. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal education</measure>
    <time_frame>1 hour</time_frame>
    <description>as informed by the patient, recorded in medical records or prenatal card and categorized as illiterate (zero), elementary school (one to nine years), high school (10 to 12 years) and higher education (&gt; 12 years) ). Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal occupation</measure>
    <time_frame>1 hour</time_frame>
    <description>as declared by the patient and noted on the medical record or prenatal card, later categorized as: health, education, general services, home, domestic, student, merchant or commerce, security, self-employed, economy, tourism, music, nutrition, computers, journalism, engineering and others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal occupation with financial income</measure>
    <time_frame>1 hour</time_frame>
    <description>as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal marital status</measure>
    <time_frame>1 hour</time_frame>
    <description>declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal origin</measure>
    <time_frame>1 hour</time_frame>
    <description>as informed by the patient and recorded in medical records, related to the city where she lives, defined as Recife, metropolitan region (Jaboatão dos Guararapes, Olinda, Paulista, Moreno, Igarassu, Abreu e Lima, Camaragibe, Cabo de Santo Agostinho, São Lourenço da Mata, Araçoiaba, Itamaracá Island, Ipojuca and Itapissuma), interior and other states.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal religion</measure>
    <time_frame>1 hour</time_frame>
    <description>according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal smoking</measure>
    <time_frame>1 hour</time_frame>
    <description>smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal alcoholism</measure>
    <time_frame>1 hour</time_frame>
    <description>habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal use of illicit drugs</measure>
    <time_frame>1 hour</time_frame>
    <description>use of non-legal drugs, such as marijuana, cocaine, crack and the like, regardless of the amount, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of pregnancies</measure>
    <time_frame>1 hour</time_frame>
    <description>number of previous pregnancies, including the current one, regardless of the gestational outcome (abortion, delivery, number of fetuses, ectopic pregnancy or fetal death), as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parity</measure>
    <time_frame>1 hour</time_frame>
    <description>number of previous deliveries with fetuses over 500g and / or gestational age greater than 22 weeks, regardless of multiple gestation, perinatal death or delivery, as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of previous cesarean sections</measure>
    <time_frame>1 hour</time_frame>
    <description>number of previous deliveries with fetuses over 500g and / or gestational age greater than the 22nd week, by cesarean section, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of previous vaginal births</measure>
    <time_frame>1 hour</time_frame>
    <description>number of previous births with fetuses above 500g and / or gestational age greater than 22 weeks, vaginally, regardless of whether instrumental, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of previous abortions</measure>
    <time_frame>1 hour</time_frame>
    <description>number of interruptions of pregnancy with fetuses below 500g and / or gestational age below 22 weeks, regardless of being spontaneous, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of children alive</measure>
    <time_frame>1 hour</time_frame>
    <description>number of children who remain alive, regardless of the cause of death, as informed by the patient and noted in medical records or prenatal card. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of prenatal consultations</measure>
    <time_frame>1 hour</time_frame>
    <description>as informed by the patient or noted on the prenatal card and medical record, the number of consultations performed during prenatal care. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age of the onset of flu-like signs and symptoms</measure>
    <time_frame>1 hour</time_frame>
    <description>gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the onset of flu-like signs and symptoms. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of puerperium days of onset of flu-like signs and symptoms</measure>
    <time_frame>14 days</time_frame>
    <description>number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of maternal symptoms</measure>
    <time_frame>1 hour</time_frame>
    <description>number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social isolation during the signs and symptoms of flu-like syndrome</measure>
    <time_frame>14 days</time_frame>
    <description>when the patient declared that at the beginning of the signs and symptoms she was separated / isolated at home without any contact with healthy people, including not even going out for essential purchases, for a period of 14 days. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social distance before the signs and symptoms of flu-like syndrome</measure>
    <time_frame>1 hour</time_frame>
    <description>it is a measure of community restraint, adopted in some cases, to prevent the spread of a certain contagious disease. Considered when the patient declared that she was at home, leaving only what was necessary for essential purchases, before the onset of signs and symptoms. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quarantine</measure>
    <time_frame>14 days</time_frame>
    <description>when the patient declared that she had contact with people infected with COVID-19 and / or traveled to places considered to be the epicenter of the disease, but even asymptomatic, she stayed home without contact with other people, including not even going out for essential purchases, for a period of seven to 14 days. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for hospitalization due to flu-like syndrome and/or complications</measure>
    <time_frame>1 hour</time_frame>
    <description>when there is a need for hospitalization due to flu-like syndrome and / or its complications, excluding hospitalizations due to obstetric complications and includes all participants, especially pregnant women monitored during prenatal care. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of hospitalization due to flu syndrome and/or complications</measure>
    <time_frame>1 hour</time_frame>
    <description>day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay due to flu-like syndrome and/or complications</measure>
    <time_frame>14 days</time_frame>
    <description>length of stay, in days, as described in the medical record. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal signs and symptoms of flu-like syndrome at diagnosis, at 6 months, 12 months and 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>As reported by the patient (dry cough, day of onset of dry cough, productive cough, day of onset of productive cough, coryza, day of onset of runny nose, body pain, day of onset of body pain, abdominal pain, day of onset of abdominal pain, chest pain, day of onset of chest pain, headache, day of onset of headache, dyspnoea, day of onset of dyspnoea, subfebrile state, day of onset of subfebrile state, fever, day of onset of fever, diarrhea , day of onset of diarrhea, sore throat, day of onset of sore throat, taste change, day of onset of taste change, smell change, day of onset of smell change, asthenia, day of onset of asthenia , axillary temperature, oxygen saturation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of polymerase chain reaction - real time (RT-PCR) for maternal COVID19 in diagnosis, at 6 months, 12 months and 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>result of RT-PCR in the diagnosis of COVID-19, by means of blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of polymerase chain reaction - real time (RT-PCR) for the differential diagnosis of maternal respiratory syndrome (viral panel)</measure>
    <time_frame>10 days</time_frame>
    <description>result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal viral panel in the diagnosis, at 6 months, 12 months and 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>result of the RT-PCR of the viral panel in the differential diagnosis of flu syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rapid test for maternal COVID-19 at diagnosis, at 6 months, 12 months and 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>result in the diagnosis of COVID-19, by means of blood, according to the usual technique, being categorized as positive, negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serial maternal IgM COVID-19</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serial maternal IgA COVID-19</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 5th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serial maternal IgG COVID-19</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>result of IgG COVID-19 serology, by means of blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 14th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serial maternal serology day</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal reinfection</measure>
    <time_frame>14 days</time_frame>
    <description>after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, from the beginning of the flu syndrome or COVID- 19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first cytokine dosage from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first blood count from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first hemoglobin measured in maternal blood, in g / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 11.0g / dL and ≤ 16.0g / dL. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocytes from maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first leukocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 4,000 / mm3 and ≤ 11,000 / mm3. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deviation to the left of the maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>when the rod / segment ratio is greater than 1/16 and / or the presence of young cells (promyelocytes, myelocytes, metamyelocytes) occurs, starting with the flu syndrome and in the period of the syndrome. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelets of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first platelet measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 150,000 / mm3 and ≤ 400,000 / mm3. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Typical lymphocytes of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first typical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 1,050 / mm3 and ≤ 3,850 / mm3. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atypical lymphocytes of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first atypical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 0 / mm3 and ≤ 220 / mm3. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first coagulogram from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diagnosis bleeding time (TB)</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first TB measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, being normal from 60s to 180s. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal diagnosis clotting time (CT)</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first CT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal prothrombin time of diagnosis (TD)</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first TD measured in maternal blood, in seconds (s), from the flu syndrome and in the period of the syndrome, with a value of up to 11.3s being normal. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal active partial thromboplastin time of diagnosis (APTT)</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first APTT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, with a value of up to 30.5s being normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International normalized ratio (INR)</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first INR measured in maternal blood, from the flu syndrome and the period of the syndrome, being normal between 2 and 3. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first urea from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urea from maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first creatinine from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transaminases in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>defined as aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP), from the beginning of the flu syndrome or COVID-19 on syndrome period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first erythrocyte sedimentation rate (VSH) of maternal diagnosis from the beginning of the flu syndrome or COVID-19:</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VSH of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal &lt;20mm / h. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first C-reactive protein (CRP) from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first CRP measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal &lt;5mg / L. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first D-dimer from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first D-dimer dosed in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DHL of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first DHL measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first alkaline phosphatase from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkaline phosphatase in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first troponin from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first troponin measured in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal &lt;0.4 ng / mL. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first ferritin from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>alue of the first ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubins in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>defined as total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first blood culture from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>result of the first blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture microorganism in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the first uroculture from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uroculture of maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>result of the first uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uroculture microorganism in maternal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgM COVID-19 worst maternal result</measure>
    <time_frame>5 days</time_frame>
    <description>worst result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, of according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgA COVID-19 worst maternal result</measure>
    <time_frame>5 days</time_frame>
    <description>Result of the worst result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 5th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal IgG COVID-19 - worst serial result</measure>
    <time_frame>14 days</time_frame>
    <description>worst result of IgG COVID-19 serology, performed using blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each kit serological test, performed after the 14th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines worst maternal outcome</measure>
    <time_frame>14 days</time_frame>
    <description>substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A , IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, being the worst maternal result, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst urea result from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urea worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst result of urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst creatinine result from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst result of creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numeric and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transaminases worst maternal outcome</measure>
    <time_frame>14 days</time_frame>
    <description>defined as the worst outcome of aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP) from the onset of the flu syndrome or COVID- 19 and in the period of the syndrome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst result of the erythrocyte sedimentation rate of maternal diagnosis (VSH) from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the worst VSH result from the flu syndrome and the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VSH worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst result of VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal &lt;20mm / h. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst C-reactive protein (CRP) result from the onset of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the worst CRP result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst CRP result measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal &lt;5mg / L. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst D-dimer result from the onset of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the worst D-dimer result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst D-dimer result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst result of lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>day of the worst DHL result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DHL worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst DHL result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkaline phosphatase worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst result of alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Troponin worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst result of troponin dosed in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal &lt;0.4 ng / mL. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>value of the worst result of ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubins worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>defined as the worst result of total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>result of the worst blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture microorganism worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>name of the microorganism, which grew on the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uroculture worse maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>result of the worst uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uroculture microorganism worst maternal result</measure>
    <time_frame>14 days</time_frame>
    <description>name of the microorganism, which grew in the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of changes in maternal chest radiography</measure>
    <time_frame>14 days</time_frame>
    <description>presence of any radiological changes, described in a medical report. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of maternal chest radiography</measure>
    <time_frame>14 days</time_frame>
    <description>description of any radiological alterations, described in a medical report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of changes in the mother's chest tomography</measure>
    <time_frame>14 days</time_frame>
    <description>presence of any changes in the tomography described in a medical report. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of normalization of the alteration of the tomography of the maternal chest</measure>
    <time_frame>14 days</time_frame>
    <description>day of the normalization of any alteration of the tomography, described in a medical report, as of the appearance. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of maternal chest tomography</measure>
    <time_frame>14 days</time_frame>
    <description>description of any alteration of the tomography described in a medical report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of maternal nasal catheter</measure>
    <time_frame>1 month</time_frame>
    <description>need for maternal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of maternal Venturi Mask</measure>
    <time_frame>1 month</time_frame>
    <description>need for Venturi mask to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prone maternal position on spontaneous ventilation</measure>
    <time_frame>1 month</time_frame>
    <description>when the patient was placed in prone position on spontaneous ventilation, face down, which was used to improve oxygenation. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of therapeutic antibiotics</measure>
    <time_frame>14 days</time_frame>
    <description>need for antibiotic therapy to treat associated bacterial infection. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of azithromycin</measure>
    <time_frame>14 days</time_frame>
    <description>need for azithromycin as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of maternal hydroxychloroquine/chloroquine</measure>
    <time_frame>14 days</time_frame>
    <description>need for hydroxychloroquine / chloroquine as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of antiparasitic drugs</measure>
    <time_frame>14 days</time_frame>
    <description>need for antiparasitic drugs as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of anticoagulant</measure>
    <time_frame>14 days</time_frame>
    <description>need for anticoagulant as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of antiretroviral</measure>
    <time_frame>14 days</time_frame>
    <description>need for antiretroviral as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of pulse therapy</measure>
    <time_frame>14 days</time_frame>
    <description>need for corticosteroid pulse therapy as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of convalescent plasma</measure>
    <time_frame>14 days</time_frame>
    <description>need for patient-cured plasma from COVID-19 (convalescent) as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assisted Mechanical Ventilation (AMV)</measure>
    <time_frame>1 month</time_frame>
    <description>need for AMV as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of neuromuscular blocker</measure>
    <time_frame>14 days</time_frame>
    <description>need for medication for neuromuscular block, such as pancuronium, as assessed by the attending physician and described in the medical record. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Extracorporeal Circulation (ECMO)</measure>
    <time_frame>1 month</time_frame>
    <description>need to use ECMO to better oxygenate the lungs and heart. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal replacement therapy (dialysis)</measure>
    <time_frame>1 month</time_frame>
    <description>need for dialysis (peritoneal or hemodialysis) as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood products</measure>
    <time_frame>1 month</time_frame>
    <description>need for blood products as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other therapeutic modalities</measure>
    <time_frame>1 month</time_frame>
    <description>need for other complementary treatments of COVID-19. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amniotic fluid in the last ultrasound examination</measure>
    <time_frame>14 days</time_frame>
    <description>defined by the amniotic fluid index (ILA) or the largest pocket, according to the experience of the ultrasonographer. The ILA will be measured in cm, being defined as the sum of the largest pockets of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 8.0 and 18.0cm), decreased (between 7.9 and 5.0cm), moderate oligohydramnios (between 4.9 and 3.0cm), severe oligohydramnios (&lt;3 , 0cm), increased (between 18.1 and 24cm) and polyhydramnios (ILA&gt; 24cm) (81.82). The largest pocket will also be measured in cm, being defined as the measure of the largest pocket of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 3.0 and 8.0cm), decreased (between 2.9 and 2.0cm), moderate oligoamine (between 1.9 and 1.0cm), severe oligoamine (&lt;1.0cm), increased (ILA between 8.1 and 12.0cm) and polyhydramnios (ILA&gt; 12.0cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal growth restriction</measure>
    <time_frame>14 days</time_frame>
    <description>defined by the Delphi procedure 2016 . Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Small fetus for gestational age (SGA)</measure>
    <time_frame>14 days</time_frame>
    <description>defined when the estimated fetal weight is &lt;10pct for gestational age and does not meet the criteria for IUGR. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of fetal morphological changes</measure>
    <time_frame>1 month</time_frame>
    <description>presence of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal morphological changes</measure>
    <time_frame>1 month</time_frame>
    <description>description of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of fetal tachycardia (FFT)</measure>
    <time_frame>1 month</time_frame>
    <description>increased FFT diagnosed by ultrasound or Doppler sonar, with sinus rhythm, when greater than 160bpm. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Doppler velocimetry parameters in the last ultrasound examination</measure>
    <time_frame>1 month</time_frame>
    <description>from the pulsatility index (PI), which is automatically calculated by the ultrasound device, using the formula: systolic peak minus the diastolic peak divided by the average speed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age of amniocentesis</measure>
    <time_frame>1 month</time_frame>
    <description>gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound of amniocentesis. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amniocentesis indications</measure>
    <time_frame>1 month</time_frame>
    <description>indication for amniocentesis, due to COVID-19 or another cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of amniocentesis for COVID19</measure>
    <time_frame>1 month</time_frame>
    <description>result of RT-PCR for COVID-19, in amniotic fluid, according to the usual technique, being categorized as positive, negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amniocentesis cytokines</measure>
    <time_frame>1 month</time_frame>
    <description>substances capable of modulating the cellular response of several cells, such as interleukins IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in amniotic fluid, in pg / ml, from the beginning of the flu syndrome or COVID-19 , and in the period of the syndrome. Numeric and continuous variable (for each cytokine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for hospitalization due to obstetric causes</measure>
    <time_frame>1 month</time_frame>
    <description>need for hospitalization due to some comorbidity or obstetric complications. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal hospital stay</measure>
    <time_frame>1 month</time_frame>
    <description>total hospital stay for any comorbidity or obstetric complications. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obesity</measure>
    <time_frame>1 month</time_frame>
    <description>calculated based on the last BMI (weight [kg] / height [m] 2), by gestational age, using the curve by Atalah et al. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic arterial hypertension (CAH)</measure>
    <time_frame>1 month</time_frame>
    <description>defined as blood pressure (BP) greater than or equal to 140 / 90mmHg, diagnosed before pregnancy, or before the 20th week of pregnancy . Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superimposed preeclampsia</measure>
    <time_frame>1 month</time_frame>
    <description>defined as CAH associated with signs of severity . Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational hypertension</measure>
    <time_frame>1 month</time_frame>
    <description>defined as BP greater than or equal to 140 / 90mmHg, diagnosed above the 20th week of pregnancy, with no signs of severity or proteinuria . Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-eclampsia</measure>
    <time_frame>1 month</time_frame>
    <description>defined as BP greater than or equal to 140 / 90mmHg, above the 20th week of pregnancy, associated with proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3 ), or target organ dysfunction, which can be categorized as severe and non-severe . Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eclampsia</measure>
    <time_frame>1 month</time_frame>
    <description>defined as BP greater than or equal to 140 / 90mmHg above the 20th week of gestation, in the presence of proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3), associated with seizures. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HELLP syndrome</measure>
    <time_frame>1 month</time_frame>
    <description>defined by the presence of hemolysis, elevated liver enzymes, decreased platelets (below 100,000 / L), elevated TGO / TGP (above 70UI / L) . Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical diabetes</measure>
    <time_frame>1 month</time_frame>
    <description>defined by the presence of one of the criteria: HbA1C ≥ 6.5% or fasting blood glucose ≥ 126mg / dl - the test should be repeated - or random blood glucose&gt; 200mg / dl, associated with symptoms of diabetes , depending on diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational diabetes</measure>
    <time_frame>1 month</time_frame>
    <description>defined by the presence of at least one of the criteria after an oral glucose tolerance test (TOTG) performed between the 24th and 28th weeks of gestation: fasting glucose ≥ 92mg / dl, or ≥ 180mg / dl (after one hour), or ≥ 153mg / dl (after two hours) , according to the diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature rupture of membranes</measure>
    <time_frame>1 month</time_frame>
    <description>spontaneous rupture of the membranes, diagnosed by anamnesis and clinical examination of the pregnant woman, before the start of labor. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature labor</measure>
    <time_frame>1 month</time_frame>
    <description>defined as the spontaneous triggering of labor before term (&lt;37 weeks), when there were above three contractions in 30 minutes and cervical alteration, according to clinical and obstetric evaluation. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placenta previa</measure>
    <time_frame>1 month</time_frame>
    <description>define when the placental insertion is low, close to the cervix, regardless of its classification (total, partial and marginal), according to ultrasound report. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abortion</measure>
    <time_frame>1 month</time_frame>
    <description>termination of pregnancy before the 22nd week and / or below 500 g, gestational age preferable, provided it is reliable, regardless of whether it is spontaneous or provoked. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normally inserted placental abruption</measure>
    <time_frame>1 month</time_frame>
    <description>defined as vaginal bleeding and / or uterine hypertonia, leading to emergency delivery, with evidence of retroplacental hematoma in the postpartum period. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal urinary tract infection</measure>
    <time_frame>1 month</time_frame>
    <description>defined when urine culture is positive for any microorganism, and treatment has been started, regardless of symptoms. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal heart disease</measure>
    <time_frame>1 month</time_frame>
    <description>presence of any congenital or acquired maternal heart disease, according to the patient's information, or diagnosed during hospitalization. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchial asthma</measure>
    <time_frame>1 month</time_frame>
    <description>as reported by the patient and / or described in the medical record presenting the diagnosis of asthma. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic obstructive pulmonary disease (COPD)</measure>
    <time_frame>1 month</time_frame>
    <description>as reported by the patient and / or described in the medical record presenting the diagnosis of COPD. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebrovascular disease</measure>
    <time_frame>1 month</time_frame>
    <description>as reported by the patient and / or described in the chart that presents the diagnosis of cerebrovascular disease. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic kidney injury</measure>
    <time_frame>1 month</time_frame>
    <description>as reported by the patient and / or described in the chart that presents the diagnosis of CRL. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunosuppression</measure>
    <time_frame>1 month</time_frame>
    <description>as reported by the patient and / or described in the chart that presents the diagnosis of immunosuppressive disease or use immunosuppressive medication. Categorical and dichotomous Yes / No type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal pneumonia</measure>
    <time_frame>1 month</time_frame>
    <description>presence of the flu syndrome associated with laboratory changes, such as leukocytosis or leukopenia, and radiological, such as localized or diffuse interstitial infiltrate, or presence of a condensation area, as diagnosed by the attending physician. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal sepsis</measure>
    <time_frame>1 month</time_frame>
    <description>life-threatening organ dysfunction resulting from an unregulated response by the body to an infection. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Septic shock</measure>
    <time_frame>1 month</time_frame>
    <description>defined as a situation of sepsis, associated with signs of hypoperfusion, with fluid-refractory hypotension and requiring vasopressor therapy (Lactate&gt; 2 mmol / L). Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe acute respiratory syndrome (SARS)</measure>
    <time_frame>1 month</time_frame>
    <description>flu-like syndrome (fever, cough, dyspnoea and other nonspecific), accompanied by oxygen saturation &lt;95% (SatO2), respiratory distress or tachypnea, hypotension and worsening of the clinical conditions of the underlying disease. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum hemorrhage</measure>
    <time_frame>14 days</time_frame>
    <description>increased postpartum bleeding, according to the assessment of the attending physician, requiring some maneuver or therapy for control. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection of the operative site</measure>
    <time_frame>14 days</time_frame>
    <description>exit of purulent secretion by the surgical scar, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometritis</measure>
    <time_frame>14 days</time_frame>
    <description>characterized by the discharge of purulent secretion from the uterine cervix, remaining dilated, with an unpleasant odor and fever for a minimum of two consecutive days, excluding the first 24 hours, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peritonitis</measure>
    <time_frame>14 days</time_frame>
    <description>characterized by abdominal pain, with compatible image examination, according to the assessment of the attending physician. Categorical and dichotomous Yes / No type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for postpartum hysterectomy</measure>
    <time_frame>1 month</time_frame>
    <description>removal of the uterus, for any indication, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of delivery</measure>
    <time_frame>1 hour</time_frame>
    <description>defined as the type of delivery performed, categorized as normal, instrumental (vacuum or forceps) or cesarean delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indication of cesarean section</measure>
    <time_frame>1 hour</time_frame>
    <description>if a cesarean section was performed, insert the indication that the attending physicians described, which can be later modified, according to the medical record evaluation by the researchers. The main indications are: dystocias, including cephalopelvic disproportion, macrosomia, impaired fetal vitality, placenta previa, cord prolapse, placental abruption, among others.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age at birth</measure>
    <time_frame>1 hour</time_frame>
    <description>gestational age at birth, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the amniocentesis. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of labor analgesia</measure>
    <time_frame>4 hours</time_frame>
    <description>use of pharmacological labor analgesia, as indicated by the attending physician and declared in medical records. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of anesthesia for cesarean section</measure>
    <time_frame>1 hour</time_frame>
    <description>method of anesthesia for performing cesarean section, categorized into spinal anesthesia, epidural and general anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antenatal corticosteroid therapy (pulmonary maturity)</measure>
    <time_frame>14 days</time_frame>
    <description>as noted in the medical records, referring to the complete course of betamethasone (12mg two doses in a 24h interval) or dexamethasone (6mg 12 / 12h, for two days), incomplete course, not taking corticosteroids or without indication for accelerating fetal lung maturity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of maternal magnesium sulphate (prophylaxis of the newborn and / or prevention of eclampsia)</measure>
    <time_frame>32 weeks</time_frame>
    <description>as noted in the medical record, magnesium sulphate for neuroprotection, before delivery and until the 32nd week of pregnancy, being categorized as complete course (performance of attack and first stage of magnesium sulfate before delivery), incomplete, not performed or without indication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal prophylactic antibiotic therapy (prophylaxis of neonatal sepsis)</measure>
    <time_frame>14 days</time_frame>
    <description>as noted in the medical records, referring to the use of the prophylactic regimen of crystalline penicillin to prevent neonatal infection with group B Streptococcus, being categorized as complete (completion of at least two phases) crystalline penicillin before delivery), incomplete, not performed or without indication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital discharge when pregnant</measure>
    <time_frame>1 month</time_frame>
    <description>when the pregnant patient was admitted and discharged while pregnant. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital discharge when puerperal</measure>
    <time_frame>1 month</time_frame>
    <description>when the pregnant or puerperal patient has been admitted and discharged in the puerperal state. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal death when pregnant</measure>
    <time_frame>1 month</time_frame>
    <description>when maternal death occurs with the pregnant patient. Categorical and dichotomous Yes / No type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal death when puerperal</measure>
    <time_frame>45 days</time_frame>
    <description>when maternal death occurs with the patient in the puerperal state. Categorical and dichotomous Yes / No type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal death</measure>
    <time_frame>10 hours</time_frame>
    <description>birth of a fetus without vitality. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perinatal death</measure>
    <time_frame>27 days</time_frame>
    <description>fetal or neonatal death (up to and including the 27th day of life). Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight</measure>
    <time_frame>1 hour</time_frame>
    <description>as measured on a standard scale, in the delivery room, in grams, and recorded in medical records. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequacy of birth weight</measure>
    <time_frame>1 hour</time_frame>
    <description>classification of birth weight, according to gestational age, being categorized as: small for gestational age (SGA), when &lt;10th pct; suitable for gestational age (AGA), when between 10º pct and 90º pct; and great for gestational age (GIG), when&gt; 90º pct.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar scores in the first minute</measure>
    <time_frame>1 minute</time_frame>
    <description>as calculated by the classic Apgar score , in the first minute of birth, recorded in medical records, which can be later categorized. Numerical and discrete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar scores in the fifth minute</measure>
    <time_frame>5 minutes</time_frame>
    <description>as calculated by the classic Apgar score, in the fifth minute of birth, recorded in medical records, which can be further categorized. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal ICU admission</measure>
    <time_frame>1 hour</time_frame>
    <description>defined as the newborn's stay in the neonatal intensive care unit after delivery, to perform any procedure. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for neonatal resuscitation</measure>
    <time_frame>27 days</time_frame>
    <description>defined as the need for resuscitation maneuvers, performed on the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for neonatal mechanical ventilation</measure>
    <time_frame>27 days</time_frame>
    <description>defined as the need for assisted mechanical ventilation, provided to the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal nasal catheter</measure>
    <time_frame>27 days</time_frame>
    <description>need for a neonatal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Continuous Positive Airway Pressure (CPAP) mask</measure>
    <time_frame>27 days</time_frame>
    <description>need for neonatal CPAP to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal hypothermia</measure>
    <time_frame>27 days</time_frame>
    <description>defined when the axillary temperature is less than or equal to 35ºC, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal hypoglycemia</measure>
    <time_frame>27 days</time_frame>
    <description>defined as peripheral blood glucose below 40mg / dl, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal infection</measure>
    <time_frame>27 days</time_frame>
    <description>defined as any neonatal infection diagnosed as noted in the medical record by neonatal care. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chorioamnionitis</measure>
    <time_frame>27 days</time_frame>
    <description>defined as the infection of the amniotic cavity, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal respiratory distress modality</measure>
    <time_frame>1 month</time_frame>
    <description>defined as newborn's respiratory distress (RDS), transient tachypnea of the newborn (NRT) or absent respiratory distress, as noted in the medical record for neonatal care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal congenital infection (TORCHS)</measure>
    <time_frame>1 month</time_frame>
    <description>defined as any congenital infection confirmed at birth, based on fetal PCR, neonatal examination or maternal serology, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Congenital malformation</measure>
    <time_frame>1 month</time_frame>
    <description>defined as any fetal congenital malformation present, as noted in medical records by neonatal care. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding</measure>
    <time_frame>1 month</time_frame>
    <description>exclusive breastfeeding, during hospitalization, by natural method or pasteurized breast milk. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord ligation</measure>
    <time_frame>10 minutes</time_frame>
    <description>can be divided into early, when performed in less than three minutes, and timely, when between three to five minutes. Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin-to-skin contact</measure>
    <time_frame>1 hour</time_frame>
    <description>as early contact was made between the mother and the baby, early, still in the delivery room. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding in the delivery room</measure>
    <time_frame>1 hour</time_frame>
    <description>according to breastfeeding, early, still in the delivery room. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of life of the newborn's diagnostic suspicion</measure>
    <time_frame>1 month</time_frame>
    <description>days of life of the newborn until the newborn's diagnostic suspicion. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of the Polymerase Chain Reaction - Real Time (RT-PCR) for neonatal COVID-19 in diagnosis, at 6 months, 12 months and 24 months</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>result of RT-PCR in the diagnosis of COVID-19, through the blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of Polymerase Chain Reaction - Real Time (RT-PCR) for the differential diagnosis of neonatal respiratory syndrome (viral panel)</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal viral panel in the diagnosis, at 6 months, 12 months and 24 months</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal cytokines</measure>
    <time_frame>6 months, 12 months and 24 months</time_frame>
    <description>substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal IgM COVID-19</measure>
    <time_frame>5 days</time_frame>
    <description>result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according with the reference values of each serological kit, performed after the 5th day of signs and symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgA COVID-19 neonatal serial</measure>
    <time_frame>5 days</time_frame>
    <description>result of IgA COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serial neonatal IgG COVID-19</measure>
    <time_frame>14 days</time_frame>
    <description>result of IgG COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 14th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal reinfection</measure>
    <time_frame>14 days</time_frame>
    <description>after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin from neonatal diagnosis</measure>
    <time_frame>14 days</time_frame>
    <description>value of the first hemoglobin measured in neonatal blood, in g / dL, from the suspicion of the diagnosis by COVID-19. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic neonatal bleeding time (BT)</measure>
    <time_frame>1 month</time_frame>
    <description>value of the first BT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic neonatal clotting time (CT)</measure>
    <time_frame>1 month</time_frame>
    <description>value of the first CT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urea from neonatal diagnosis</measure>
    <time_frame>1 month</time_frame>
    <description>value of the first urea measured in neonatal blood, in mg / dL, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine from neonatal diagnosis</measure>
    <time_frame>1 month</time_frame>
    <description>value of the first creatinine measured in neonatal blood, in mg / dL, based on the suspected diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transaminases of the neonatal diagnosis</measure>
    <time_frame>1 month</time_frame>
    <description>defined as aspartate aminotransferase or glutamic-oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase, based on the suspicion of the diagnosis by COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture of the neonatal diagnosis</measure>
    <time_frame>1 month</time_frame>
    <description>result of the first blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uroculture of neonatal diagnosis</measure>
    <time_frame>1 month</time_frame>
    <description>result of the first urine culture, based on the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgM COVID-19 - worst neonatal result</measure>
    <time_frame>5 days</time_frame>
    <description>worst result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate , according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal IgG COVID-19 - worst serial result</measure>
    <time_frame>14 days</time_frame>
    <description>worst result of IgG COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 14th day of signs and symptoms. Numeric and continuous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines - worst neonatal result</measure>
    <time_frame>14 days</time_frame>
    <description>worst result of cytokines, substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12 , IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from suspected diagnosis. Numeric and continuous variable (for each cytokine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst blood count result from the beginning of the suspected diagnosis by COVID-19</measure>
    <time_frame>1 month</time_frame>
    <description>day of the worst blood count result, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of the worst value of the neonatal coagulogram from the suspicion of the diagnosis by COVID-19</measure>
    <time_frame>1 month</time_frame>
    <description>day of the realization of the worst value of the coagulogram, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding time - worst neonatal result (BT)</measure>
    <time_frame>1 month</time_frame>
    <description>value of the worst BT result measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urea - worst neonatal result</measure>
    <time_frame>1 month</time_frame>
    <description>value of the worst result of urea measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine - worst neonatal result</measure>
    <time_frame>1 month</time_frame>
    <description>value of the worst result of creatinine measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transaminases - worst neonatal result</measure>
    <time_frame>1 month</time_frame>
    <description>defined as the worst result of aspartate aminotransferase (AST) or glutamic oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase measurements, from the beginning of suspected COVID-19 diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture - worst neonatal result</measure>
    <time_frame>1 month</time_frame>
    <description>result of the worst blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uroculture - worst neonatal result</measure>
    <time_frame>1 month</time_frame>
    <description>result of the worst urine culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gasometry - worst neonatal result</measure>
    <time_frame>1 hour</time_frame>
    <description>defined as the worst result of measuring hydrogen potential, excess of bases, bicarbonate, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2) and oxygenation index, in neonatal arterial blood, from the beginning of suspected COVID-19 diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of RT-PCR of the placenta</measure>
    <time_frame>1 month</time_frame>
    <description>result of RT-PCR in the diagnosis of COVID-19, through the placenta, according to the usual technique, being categorized as positive, negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental viral panel</measure>
    <time_frame>1 month</time_frame>
    <description>result of the RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through the placenta, according to the technique and kit used, categorized according to the virus found.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathological of the placenta</measure>
    <time_frame>1 month</time_frame>
    <description>result of the histopathological of the placenta, according to the usual technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of RT-PCR in breast milk at diagnosis, at birth and with and at hospital discharge</measure>
    <time_frame>1 month</time_frame>
    <description>result of RT-PCR in the diagnosis of COVID-19, using breast milk, according to the usual technique, being categorized as positive, negative and indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral panel in breast milk</measure>
    <time_frame>1 month</time_frame>
    <description>result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through breast milk, according to the technique and kit used, categorized according to the virus found.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of alteration of the neonatal chest radiography</measure>
    <time_frame>1 day</time_frame>
    <description>presence of any radiological alteration, described in a medical report. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of neonatal chest radiography</measure>
    <time_frame>1 day</time_frame>
    <description>description of any radiological changes, according to a medical report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of alteration of the neonatal chest tomography</measure>
    <time_frame>1 day</time_frame>
    <description>presence of any alteration of the tomography, described in a medical report. Yes / No categorical and dichotomous variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Result of neonatal chest tomography</measure>
    <time_frame>1 day</time_frame>
    <description>description of any alteration of the tomography, according to a medical report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Head circumference</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Weight</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Height</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>measured by the assistant pediatrician as noted on the prenatal card, in cm. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of the newborn up to 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as adequate, when all are present, and inappropriate, if any of the situations is absent: the baby is firmer and already sits with support; he turns around and rolls from side to side; grabs toys like rings and rattles, holding tight and resisting if someone tries to take them out of your hand; and when he hears some noise, he turns his head to find where it comes from.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of the newborn up to 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inappropriate, if any of the situations is absent: the baby can stand up, leaning on furniture or with the help of a person; clap your hands, you can point with your finger what you want to catch and have fun saying goodbye; and you may be speaking a word or two like mom, pope, give.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of the newborn up to 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inadequate, if any of the situations is absent: start to put two words together and speak simple phrases like &quot;where's the cat?&quot; or &quot;milk not&quot;; he demonstrates his own will, tests limits and speaks the word &quot;no&quot; a lot; climbs on chairs and sofas. Run, go up and down stairs, standing, with the help of an adult; can help to dress; and you can start to learn how to control pee and poop.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">180</enrollment>
  <condition>COVID19</condition>
  <condition>Coronavirus Infection</condition>
  <condition>Pregnancy Disease</condition>
  <condition>Severe Acute Respiratory Syndrome</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant and postpartum women admitted with flu syndrome in six reference centers in the&#xD;
        Northeast of Brazil.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant or puerperal women;&#xD;
&#xD;
          -  Diagnosis of flu syndrome on admission;&#xD;
&#xD;
          -  Testing for COVID-19 performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical impossibility of signing the Informed Consent Form (ICF), either by the&#xD;
             patient or guardian (in the prospective arm);&#xD;
&#xD;
          -  Incomplete or not located medical records (retrospective arm).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>LEILA KATZ, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Materno Infantil Prof. Fernando Figueira</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Materno Infantil Prof. Fernando Figueira</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50.070-550</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Materno Infantil Prof. Fernando Figueira</investigator_affiliation>
    <investigator_full_name>Leila Katz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>coronavirus</keyword>
  <keyword>COVID-19</keyword>
  <keyword>coronavirus infection</keyword>
  <keyword>severe acute respiratory syndrome</keyword>
  <keyword>coronavirus 2</keyword>
  <keyword>SRAS-CoV-2</keyword>
  <keyword>pregnancy</keyword>
  <keyword>maternal mortality</keyword>
  <keyword>perinatal mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04462367
org study id: NCOVIP
nct id: NCT04462367
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective and retrospective cohort study. The objective will to determine the frequency
      of COVID-19 in pregnant and postpartum women hospitalized with flu syndrome, to evaluate
      clinical and laboratory predictors of COVID-19 progression and to determine the factors
      associated with adverse maternal and perinatal outcomes in healthcare centers in two states
      of Northeast Brazil.The study will be conducted including pregnant and postpartum women with
      clinical or laboratorial diagnosis of COVID-19, admitted in six healthcare centers in the
      Northeast of Brazil. All pregnant and postpartum women with clinical and/or diagnosis of
      COVID-19, attended in prenatal care, in emergency (maternity triage), high-risk pregnancy
      ward, obstetric intensive care unit and rooming-in ward will be included. The data will be
      collected in specific forms. The exams will be carried out by trained professionals within
      each institution.
General Objective: To determine the frequency of COVID-19 in pregnant and postpartum women
      admitted with flu syndrome, to evaluate the clinical and laboratory predictors of COVID-19
      progression and to identify the factors associated with adverse maternal and perinatal /
      neonatal outcomes in six reference centers in the Northeast of Brazil.

      Specific objectives

      In pregnant and postpartum women admitted to the four institutions involved with flu-like
      symptoms or SARS:

        1. To describe the biological characteristics (maternal age and pre-pregnancy maternal
           weight, maternal height, pre-gestational body mass index - BMI and pre-gestational
           nutritional classification), sociodemographic characteristics (color, number of people
           living in the household, per capita family income, education, occupation, occupation,
           marital status, origin and religion), habits (smoking, drinking and use of illicit
           drugs), obstetric characteristics (number of pregnancies, parity, previous vaginal
           delivery and previous cesarean, previous abortions, number live children, entry into the
           study and number of prenatal consultations) and the service of origin (IMIP, HDM, ISEA
           or MFD);

        2. To describe the clinical characteristics (gestational age or postpartum days at the
           beginning of signs and symptoms, duration of symptoms, isolation, social distance and
           quarantine before signs and symptoms, need for hospitalization due to infection and / or
           complications, day of hospitalization due to flu-like syndrome and / or complications,
           length of hospital stay due to flu-like syndrome and / or complications and the main
           related signs and symptoms and days of onset - dry or productive cough, runny nose, sore
           throat, body pain, abdominal pain , chest pain, headache, smell and taste changes,
           dyspnoea, subfebrile state and fever, diarrhea, asthenia, saturation level, axillary
           temperature and mild / moderate signs and symptoms);

        3. To determine the frequency of COVID-19 infection according to the results of diagnostic
           tests (rapid test, RT-PCR and serology) applied during hospitalization;

        4. To describe the maternal laboratory parameters at the time of the diagnosis of influenza
           syndrome and the worst laboratory tests (result of RT-PCR for COVID-19, result of viral
           panel and type of virus, serology for COVID-19 - IgM, IgA and serial IgG, inflammatory
           cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4,
           IL-1β, IL-9, IL-15, Interferon - IFN-γ, tumor necrosis factor - TNF-α, blood count,
           coagulogram, urea, creatinine, transaminases - ALT, AST, erythrocyte sedimentation rate
           - VSH, C reactive protein - CRP), D-dimer, lactic dehydrogenase - LDH, alkaline
           phosphatase, bilirubins, ferritin, troponin, blood culture, urine culture, blood gas
           analysis and day of all tests);

        5. To describe the radiological findings (chest X-rays, computed tomography), the pulmonal
           ultrasonography and day of exam alteration and normalization;

        6. To describe the therapeutic modalities performed (oxygen therapy - nasal catheter or
           Venturi with its maximum flows, use of prone in spontaneous ventilation and / or
           mechanical ventilation, use of mechanical ventilation, use of neuromuscular blocker, use
           of extracorporeal membrane oxygenation - ECMO, use of: antibiotics, azithromycin,
           hydroxychloroquine / chloroquine, antiparasitic drugs such as ivermectin, anticoagulant
           and / or antiretroviral, pulse therapy, convalescent plasma, need for renal replacement
           therapy, blood products and others, start day and duration of all therapeutic modalities
           performed);

        7. To describe the characteristics of obstetric ultrasound (tachycardia, frequency of
           diagnosis of fetal growth restriction, fetus small for gestational age - SGA, changes in
           amniotic fluid and fetal morphological changes) performed during the course of infection
           and post-infection follow-up;

        8. To describe the doppler velocimetric parameters of the uterine and fetal circulation
           (pulsatility index of the middle uterine arteries, the middle fetal cerebral artery -
           MCA, the umbilical artery, the venous duct, the frequency of changes in the doppler
           velocimetry of all the vessels studied and the speed of the systolic peak in MCA) during
           infection and in the post-infection follow-up;

        9. To describe invasive intrauterine diagnostic procedures (amniocentesis), gestational age
           at which amniocentesis was performed, indications, results of the RT-PCR test for
           COVID-19, results of the TORCHS survey, results of the karyotype and results of the
           inflammatory cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13,
           IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN- γ, tumor necrosis factor - TNF-α;

       10. To determine comorbidities / complications associated with pregnancy or the puerperium
           (need for hospitalization due to obstetric causes, length of hospital stay, obesity,
           multiple pregnancy, hypertensive syndromes, diabetes - clinical or gestational, heart
           disease, chronic obstructive pulmonary disease, bronchial asthma, cerebrovascular
           disease, renal failure, immunosuppression, severe acute respiratory syndrome - SARS,
           premature rupture of membranes, premature labor, placenta praevia, urinary tract
           infection, pneumonia, sepsis, septic shock, abortion, abruptio placenta, postpartum
           hemorrhage, infection of surgical site, endometritis, peritonitis, thromboembolic
           events, need for postpartum hysterectomy, need for other surgeries after delivery and
           tubal ligation, maternal near miss criteria);

       11. To describe the delivery outcomes (type of delivery - vaginal, spontaneous or operative,
           or cesarean section, indication for cesarean section, indication for labor induction,
           method of labor induction, duration of induction, gestational age at delivery, use of
           labor analgesia, type of anesthesia for cesarean section);

       12. To describe prenatal interventions (antenatal corticosteroid therapy - number of doses,
           use of magnesium sulfate and prophylactic antibiotic therapy);

       13. To describe the final maternal outcome (discharge of the pregnant woman, discharge of
           the postpartum woman, death of the pregnant woman and death of the postpartum woman);

       14. To describe perinatal and neonatal outcomes (fetal death, perinatal death, birth weight,
           birth weight adequacy - SGA, AGA, LGA, Apgar scores in the first and fifth minutes, need
           for neonatal resuscitation, ICU admission, need for assisted mechanical ventilation,
           oxygen therapy, oxygen therapy modalities, hypothermia, hypoglycemia, polycythemia,
           anemia, neonatal infection, chorioamnionitis, type of respiratory distress,
           breastfeeding, neonatal congenital infections (TORCHS), congenital malformation, other
           neonatal morbidities, neonatal near miss, neonatal death, days of life of neonatal death
           and length of hospital stay and in neonatal ICU);

       15. To determine the procedures in neonatal care in the delivery room (cord clamping - early
           or opportune, skin-to-skin contact, breastfeeding in the delivery room) and,
           subsequently, rooming-in or admission to a neonatal ICU / nursing unit;

       16. To describe the neonatal laboratory parameters of the suspected diagnosis or
           confirmation of COVID-19 and the worst test results (days of life of the newborn's
           suspected diagnosis, result of rapid neonate test, RT-PCR for COVID-19 in nasopharyngeal
           swab , result of viral panel and virus type, serology for COVID-19 - IgM, IgA and IgG
           serial, inflammatory cytokines - interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL -12,
           IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ, tumor necrosis factor -
           TNF-α, blood count, coagulogram, urea, creatinine, transaminases - ALT, AST, erythrocyte
           sedimentation rate - VSH, C-reactive protein - CRP), D-dimer, lactic dehydrogenase -
           LDH, alkaline phosphatase, bilirubins, ferritin, troponin, blood culture, urine culture,
           blood gas analysis and day of all tests);

       17. To describe the laboratory parameters in the placenta (result of RT-PCR / viral panel by
           swab and anatomopathological study) and in cord blood (RT-PCR);

       18. To determine the frequency of vertical transmission and the factors associated with a
           higher risk of its occurrence (gestational age at infection, severity of infection,
           laboratory markers, type of delivery, labor, cord clamping practice, placental findings,
           maternal interleukins);

       19. To describe the laboratory parameters in breast milk (result of RT-PCR / viral panel);

       20. To describe the neonatal imaging exams (chest X-rays, computed tomography and day of
           exam changes and normalization);

       21. To determine the association of biological, sociodemographic, obstetric variables,
           habits, clinical, maternal laboratory parameters in the diagnosis and the worst result,
           radiological findings, therapeutic modalities, ultrasound and doppler velocimetric
           characteristics, invasive procedures, comorbidities / complications and characteristics
           of childbirth with adverse maternal outcome (maternal near miss and maternal death).

       22. To determine the association of biological, sociodemographic, obstetric variables,
           habits, clinical, maternal laboratory parameters in the diagnosis and the worst result,
           radiological findings, therapeutic modalities, ultrasound and doppler velocimetric
           characteristics, invasive procedures, comorbidities / complications, delivery results,
           prenatal interventions, final pregnancy outcome, delivery room procedures, neonatal care
           and neonatal laboratory parameters, placenta, amniotic fluid and breast milk with
           adverse perinatal / neonatal outcome (neonatal near miss and fetal / neonatal death);

       23. To analyze maternal and perinatal mortality according to gestational age at the onset of
           symptoms (Kaplan-Meier survival curve);

       24. To compare data from two states in Northeast Brazil with official general data in the
           country according to the Ministry of Health for the pregnancy-puerperal cycle.

       25. In a subset of women routinely assessed on admission through the rapid test (ISEA and
           Unimed-João Pessoa), to determine the frequency of positive rapid test, positive RT-PCR,
           associated symptoms, asymptomatic carriers and to compare maternal and perinatal
           outcomes according to test results.

       26. To carry out long-term monitoring of women and babies included in the cohort in 2020, to
           detect recurrence of symptoms, frequency of reinfection, evolution of laboratory
           parameters (repetition of RT-PCR and serology) and monitoring of growth and development
           in the cohort of children aged six months, 12 and 24 months.

      Methods: A prospective and retrospective cohort study will be conducted including pregnant
      and postpartum women with clinical or laboratorial diagnosis of COVID-19, admitted in six
      healthcare centers in the Northeast of Brazil. All pregnant and postpartum women with
      clinical and/or diagnosis of COVID-19, attended in prenatal care, in emergency (maternity
      triage), high-risk pregnancy ward, obstetric intensive care unit and rooming-in ward will be
      included. The data will be collected in specific forms. The exams will be carried out by
      trained professionals within each institution. A database will be created on the RedCap
      platform. For the association of dependent variables (maternal mortality / near miss and
      unfavorable perinatal outcomes) with independent variables (biological, sociodemographic
      characteristics, history, clinical characteristics, ultrasound modifications, doppler
      velocimetric and laboratory tests, chi-square tests will be used and Fisher's exact, when
      pertinent, with a significance level of 5%. The relative risk and its 95% confidence interval
      will also be calculated to determine the strength of association between the variables.
      outcomes, Student t or Mann-Whitney tests will be adopted. A multivariate analysis will be
      performed to determine the variables that will actually remain associated, in addition, a
      Kaplan-Meier survival curve will be constructed.
observational model: Cohort
time perspective: Other
measure: Near miss maternal:
time frame: 42 days
description: Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.
measure: Maternal death
time frame: 42 days
description: It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.
measure: Near miss neonate
time frame: 7 days
description: It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar <7 in the 5th minute, birth weight <1,750 grams or gestational age <33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.
measure: Neonatal death
time frame: 27 days
description: Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.
measure: Early neonatal death
time frame: 7 days
description: Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable
measure: Fetal death
time frame: 1 hour
description: Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.
measure: Perinatal death
time frame: 7 days
description: Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.
measure: Maternal age
time frame: 1 hour
description: Calculated based on the date of birth recorded in the medical record, hospital identification data, or according to the patient's information, in full years. Numerical and discrete variable.
measure: Maternal pre-pregnancy weight
time frame: 1 hour
description: maternal weight before pregnancy, in kilogram (kg), according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.
measure: Maternal height
time frame: 1 hour
description: expressed, in meters, according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.
measure: Pre-gestational nutritional classification
time frame: 1 hour
description: classified according to pre-gestational BMI: low weight grade III (≤ 16.00), low weight grade II (≥ 16.00 to <16.99), low weight grade I (≥ 17 , 00 to <18.49), ideal weight (≥ 18.50 to <24.99), overweight (≥ 25.00 to <29.99), grade I obesity (≥ 30.00 to <34.99) , grade II obesity (≥35.00 to <39.99) and grade III obesity (≥ 40.00).
measure: Pre-gestational body mass index (BMI)
time frame: 1 hour
description: expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.
measure: Maternal color
time frame: 1 hour
description: according to the patient's self-declaration and collected according to information and / or recorded in the medical record or prenatal card in black, white, brown, yellow and indigenous.
measure: Number of people living in the household
time frame: 1 hour
description: defined as the number of people, regardless of age, living in the same household, collected according to the patient's information. Numerical and discrete variable.
measure: Family income per capita
time frame: 1 hour
description: collected according to the patient's information as the sum of the monthly income of all members living in the household, including benefits from social programs and informal income. Categorized in: up to 1 minimum wage; 1 to 2 minimum wages; 3 to 5 minimum wages; more than 5 minimum wages. Numerical and discrete variable.
measure: Maternal education
time frame: 1 hour
description: as informed by the patient, recorded in medical records or prenatal card and categorized as illiterate (zero), elementary school (one to nine years), high school (10 to 12 years) and higher education (> 12 years) ). Numerical and discrete variable.
measure: Maternal occupation
time frame: 1 hour
description: as declared by the patient and noted on the medical record or prenatal card, later categorized as: health, education, general services, home, domestic, student, merchant or commerce, security, self-employed, economy, tourism, music, nutrition, computers, journalism, engineering and others.
measure: Maternal occupation with financial income
time frame: 1 hour
description: as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.
measure: Maternal marital status
time frame: 1 hour
description: declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.
measure: Maternal origin
time frame: 1 hour
description: as informed by the patient and recorded in medical records, related to the city where she lives, defined as Recife, metropolitan region (Jaboatão dos Guararapes, Olinda, Paulista, Moreno, Igarassu, Abreu e Lima, Camaragibe, Cabo de Santo Agostinho, São Lourenço da Mata, Araçoiaba, Itamaracá Island, Ipojuca and Itapissuma), interior and other states.
measure: Maternal religion
time frame: 1 hour
description: according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.
measure: Maternal smoking
time frame: 1 hour
description: smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.
measure: Maternal alcoholism
time frame: 1 hour
description: habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.
measure: Maternal use of illicit drugs
time frame: 1 hour
description: use of non-legal drugs, such as marijuana, cocaine, crack and the like, regardless of the amount, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.
measure: Number of pregnancies
time frame: 1 hour
description: number of previous pregnancies, including the current one, regardless of the gestational outcome (abortion, delivery, number of fetuses, ectopic pregnancy or fetal death), as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
measure: Parity
time frame: 1 hour
description: number of previous deliveries with fetuses over 500g and / or gestational age greater than 22 weeks, regardless of multiple gestation, perinatal death or delivery, as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
measure: Number of previous cesarean sections
time frame: 1 hour
description: number of previous deliveries with fetuses over 500g and / or gestational age greater than the 22nd week, by cesarean section, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
measure: Number of previous vaginal births
time frame: 1 hour
description: number of previous births with fetuses above 500g and / or gestational age greater than 22 weeks, vaginally, regardless of whether instrumental, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
measure: Number of previous abortions
time frame: 1 hour
description: number of interruptions of pregnancy with fetuses below 500g and / or gestational age below 22 weeks, regardless of being spontaneous, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.
measure: Number of children alive
time frame: 1 hour
description: number of children who remain alive, regardless of the cause of death, as informed by the patient and noted in medical records or prenatal card. Numerical and discrete variable.
measure: Number of prenatal consultations
time frame: 1 hour
description: as informed by the patient or noted on the prenatal card and medical record, the number of consultations performed during prenatal care. Numerical and discrete variable.
measure: Gestational age of the onset of flu-like signs and symptoms
time frame: 1 hour
description: gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the onset of flu-like signs and symptoms. Numerical and discrete variable.
measure: Number of puerperium days of onset of flu-like signs and symptoms
time frame: 14 days
description: number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.
measure: Duration of maternal symptoms
time frame: 1 hour
description: number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.
measure: Social isolation during the signs and symptoms of flu-like syndrome
time frame: 14 days
description: when the patient declared that at the beginning of the signs and symptoms she was separated / isolated at home without any contact with healthy people, including not even going out for essential purchases, for a period of 14 days. Yes / No categorical and dichotomous variable.
measure: Social distance before the signs and symptoms of flu-like syndrome
time frame: 1 hour
description: it is a measure of community restraint, adopted in some cases, to prevent the spread of a certain contagious disease. Considered when the patient declared that she was at home, leaving only what was necessary for essential purchases, before the onset of signs and symptoms. Yes / No categorical and dichotomous variable.
measure: Quarantine
time frame: 14 days
description: when the patient declared that she had contact with people infected with COVID-19 and / or traveled to places considered to be the epicenter of the disease, but even asymptomatic, she stayed home without contact with other people, including not even going out for essential purchases, for a period of seven to 14 days. Yes / No categorical and dichotomous variable.
measure: Need for hospitalization due to flu-like syndrome and/or complications
time frame: 1 hour
description: when there is a need for hospitalization due to flu-like syndrome and / or its complications, excluding hospitalizations due to obstetric complications and includes all participants, especially pregnant women monitored during prenatal care. Yes / No categorical and dichotomous variable.
measure: Day of hospitalization due to flu syndrome and/or complications
time frame: 1 hour
description: day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.
measure: Length of hospital stay due to flu-like syndrome and/or complications
time frame: 14 days
description: length of stay, in days, as described in the medical record. Numerical and discrete variable.
measure: Maternal signs and symptoms of flu-like syndrome at diagnosis, at 6 months, 12 months and 24 months
time frame: 24 months
description: As reported by the patient (dry cough, day of onset of dry cough, productive cough, day of onset of productive cough, coryza, day of onset of runny nose, body pain, day of onset of body pain, abdominal pain, day of onset of abdominal pain, chest pain, day of onset of chest pain, headache, day of onset of headache, dyspnoea, day of onset of dyspnoea, subfebrile state, day of onset of subfebrile state, fever, day of onset of fever, diarrhea , day of onset of diarrhea, sore throat, day of onset of sore throat, taste change, day of onset of taste change, smell change, day of onset of smell change, asthenia, day of onset of asthenia , axillary temperature, oxygen saturation).
measure: Result of polymerase chain reaction - real time (RT-PCR) for maternal COVID19 in diagnosis, at 6 months, 12 months and 24 months
time frame: 24 months
description: result of RT-PCR in the diagnosis of COVID-19, by means of blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.
measure: Result of polymerase chain reaction - real time (RT-PCR) for the differential diagnosis of maternal respiratory syndrome (viral panel)
time frame: 10 days
description: result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.
measure: Maternal viral panel in the diagnosis, at 6 months, 12 months and 24 months
time frame: 24 months
description: result of the RT-PCR of the viral panel in the differential diagnosis of flu syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.
measure: Rapid test for maternal COVID-19 at diagnosis, at 6 months, 12 months and 24 months
time frame: 24 months
description: result in the diagnosis of COVID-19, by means of blood, according to the usual technique, being categorized as positive, negative and indeterminate.
measure: Serial maternal IgM COVID-19
time frame: 6 months, 12 months and 24 months
description: result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.
measure: Serial maternal IgA COVID-19
time frame: 6 months, 12 months and 24 months
description: result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 5th day of signs and symptoms. Numeric and continuous variable.
measure: Serial maternal IgG COVID-19
time frame: 6 months, 12 months and 24 months
description: result of IgG COVID-19 serology, by means of blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 14th day of signs and symptoms. Numeric and continuous variable.
measure: Serial maternal serology day
time frame: 6 months, 12 months and 24 months
description: rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.
measure: Maternal reinfection
time frame: 14 days
description: after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.
measure: Cytokines in maternal diagnosis
time frame: 14 days
description: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, from the beginning of the flu syndrome or COVID- 19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).
measure: Day of the first cytokine dosage from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Day of the first blood count from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Hemoglobin of maternal diagnosis
time frame: 14 days
description: value of the first hemoglobin measured in maternal blood, in g / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 11.0g / dL and ≤ 16.0g / dL. Numeric and continuous variable.
measure: Leukocytes from maternal diagnosis
time frame: 14 days
description: value of the first leukocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 4,000 / mm3 and ≤ 11,000 / mm3. Numerical and discrete variable.
measure: Deviation to the left of the maternal diagnosis
time frame: 14 days
description: when the rod / segment ratio is greater than 1/16 and / or the presence of young cells (promyelocytes, myelocytes, metamyelocytes) occurs, starting with the flu syndrome and in the period of the syndrome. Yes / No categorical and dichotomous variable.
measure: Platelets of maternal diagnosis
time frame: 14 days
description: value of the first platelet measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 150,000 / mm3 and ≤ 400,000 / mm3. Numerical and discrete variable.
measure: Typical lymphocytes of maternal diagnosis
time frame: 14 days
description: value of the first typical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 1,050 / mm3 and ≤ 3,850 / mm3. Numerical and discrete variable.
measure: Atypical lymphocytes of maternal diagnosis
time frame: 14 days
description: value of the first atypical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 0 / mm3 and ≤ 220 / mm3. Numerical and discrete variable.
measure: Day of the first coagulogram from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Maternal diagnosis bleeding time (TB)
time frame: 14 days
description: value of the first TB measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, being normal from 60s to 180s. Numerical and discrete variable.
measure: Maternal diagnosis clotting time (CT)
time frame: 14 days
description: value of the first CT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
measure: Maternal prothrombin time of diagnosis (TD)
time frame: 14 days
description: value of the first TD measured in maternal blood, in seconds (s), from the flu syndrome and in the period of the syndrome, with a value of up to 11.3s being normal. Numerical and discrete variable.
measure: Maternal active partial thromboplastin time of diagnosis (APTT)
time frame: 14 days
description: value of the first APTT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, with a value of up to 30.5s being normal.
measure: International normalized ratio (INR)
time frame: 14 days
description: value of the first INR measured in maternal blood, from the flu syndrome and the period of the syndrome, being normal between 2 and 3. Numerical and discrete variable.
measure: Day of the first urea from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Urea from maternal diagnosis
time frame: 14 days
description: value of the first urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.
measure: Day of the first creatinine from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Creatinine of maternal diagnosis
time frame: 14 days
description: value of the first creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numerical and discrete variable.
measure: Transaminases in maternal diagnosis
time frame: 14 days
description: defined as aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP), from the beginning of the flu syndrome or COVID-19 on syndrome period.
measure: Day of the first erythrocyte sedimentation rate (VSH) of maternal diagnosis from the beginning of the flu syndrome or COVID-19:
time frame: 14 days
description: day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: VSH of maternal diagnosis
time frame: 14 days
description: value of the first VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.
measure: Day of the first C-reactive protein (CRP) from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: CRP of maternal diagnosis
time frame: 14 days
description: value of the first CRP measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.
measure: Day of the first D-dimer from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: D-dimer of maternal diagnosis
time frame: 14 days
description: value of the first D-dimer dosed in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
measure: Day of the first lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: DHL of maternal diagnosis
time frame: 14 days
description: value of the first DHL measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.
measure: Day of the first alkaline phosphatase from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Alkaline phosphatase in maternal diagnosis
time frame: 14 days
description: value of the first alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.
measure: Day of the first troponin from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Troponin in maternal diagnosis
time frame: 14 days
description: value of the first troponin measured in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.
measure: Day of the first ferritin from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Ferritin in maternal diagnosis
time frame: 14 days
description: alue of the first ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
measure: Bilirubins in maternal diagnosis
time frame: 14 days
description: defined as total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.
measure: Day of the first blood culture from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Blood culture of maternal diagnosis
time frame: 14 days
description: result of the first blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: Blood culture microorganism in maternal diagnosis
time frame: 14 days
description: name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
measure: Day of the first uroculture from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Uroculture of maternal diagnosis
time frame: 14 days
description: result of the first uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: Uroculture microorganism in maternal diagnosis
time frame: 14 days
description: name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
measure: IgM COVID-19 worst maternal result
time frame: 5 days
description: worst result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, of according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.
measure: IgA COVID-19 worst maternal result
time frame: 5 days
description: Result of the worst result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 5th day of signs and symptoms. Numeric and continuous variable.
measure: Maternal IgG COVID-19 - worst serial result
time frame: 14 days
description: worst result of IgG COVID-19 serology, performed using blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each kit serological test, performed after the 14th day of signs and symptoms. Numeric and continuous variable.
measure: Cytokines worst maternal outcome
time frame: 14 days
description: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A , IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, being the worst maternal result, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).
measure: Day of the worst urea result from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Urea worst maternal result
time frame: 14 days
description: value of the worst result of urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.
measure: Day of the worst creatinine result from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: Creatinine worst maternal result
time frame: 14 days
description: value of the worst result of creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numeric and discrete variable.
measure: Transaminases worst maternal outcome
time frame: 14 days
description: defined as the worst outcome of aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP) from the onset of the flu syndrome or COVID- 19 and in the period of the syndrome.
measure: Day of the worst result of the erythrocyte sedimentation rate of maternal diagnosis (VSH) from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the worst VSH result from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
measure: VSH worst maternal result
time frame: 14 days
description: value of the worst result of VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.
measure: Day of the worst C-reactive protein (CRP) result from the onset of the flu syndrome or COVID-19
time frame: 14 days
description: day of the worst CRP result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: CRP worst maternal result
time frame: 14 days
description: value of the worst CRP result measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.
measure: Day of the worst D-dimer result from the onset of the flu syndrome or COVID-19
time frame: 14 days
description: day of the worst D-dimer result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: D-dimer worst maternal result
time frame: 14 days
description: value of the worst D-dimer result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
measure: Day of the worst result of lactic dehydrogenase (DHL) from the beginning of the flu syndrome or COVID-19
time frame: 14 days
description: day of the worst DHL result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.
measure: DHL worst maternal result
time frame: 14 days
description: value of the worst DHL result measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.
measure: Alkaline phosphatase worst maternal result
time frame: 14 days
description: value of the worst result of alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.
measure: Troponin worst maternal result
time frame: 14 days
description: value of the worst result of troponin dosed in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.
measure: Ferritin worst maternal result
time frame: 14 days
description: value of the worst result of ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.
measure: Bilirubins worst maternal result
time frame: 14 days
description: defined as the worst result of total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.
measure: Blood culture worst maternal result
time frame: 14 days
description: result of the worst blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: Blood culture microorganism worst maternal result
time frame: 14 days
description: name of the microorganism, which grew on the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
measure: Uroculture worse maternal result
time frame: 14 days
description: result of the worst uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: Uroculture microorganism worst maternal result
time frame: 14 days
description: name of the microorganism, which grew in the exam, in the worst maternal result, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.
measure: Presence of changes in maternal chest radiography
time frame: 14 days
description: presence of any radiological changes, described in a medical report. Yes / No categorical and dichotomous variable.
measure: Result of maternal chest radiography
time frame: 14 days
description: description of any radiological alterations, described in a medical report.
measure: Presence of changes in the mother's chest tomography
time frame: 14 days
description: presence of any changes in the tomography described in a medical report. Yes / No categorical and dichotomous variable.
measure: Day of normalization of the alteration of the tomography of the maternal chest
time frame: 14 days
description: day of the normalization of any alteration of the tomography, described in a medical report, as of the appearance. Numerical and discrete variable.
measure: Result of maternal chest tomography
time frame: 14 days
description: description of any alteration of the tomography described in a medical report.
measure: Use of maternal nasal catheter
time frame: 1 month
description: need for maternal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
measure: Use of maternal Venturi Mask
time frame: 1 month
description: need for Venturi mask to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
measure: Prone maternal position on spontaneous ventilation
time frame: 1 month
description: when the patient was placed in prone position on spontaneous ventilation, face down, which was used to improve oxygenation. Yes / No categorical and dichotomous variable.
measure: Use of therapeutic antibiotics
time frame: 14 days
description: need for antibiotic therapy to treat associated bacterial infection. Yes / No categorical and dichotomous variable.
measure: Use of azithromycin
time frame: 14 days
description: need for azithromycin as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
measure: Use of maternal hydroxychloroquine/chloroquine
time frame: 14 days
description: need for hydroxychloroquine / chloroquine as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
measure: Use of antiparasitic drugs
time frame: 14 days
description: need for antiparasitic drugs as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
measure: Use of anticoagulant
time frame: 14 days
description: need for anticoagulant as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
measure: Use of antiretroviral
time frame: 14 days
description: need for antiretroviral as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
measure: Use of pulse therapy
time frame: 14 days
description: need for corticosteroid pulse therapy as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
measure: Use of convalescent plasma
time frame: 14 days
description: need for patient-cured plasma from COVID-19 (convalescent) as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.
measure: Assisted Mechanical Ventilation (AMV)
time frame: 1 month
description: need for AMV as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.
measure: Use of neuromuscular blocker
time frame: 14 days
description: need for medication for neuromuscular block, such as pancuronium, as assessed by the attending physician and described in the medical record. Yes / No categorical and dichotomous variable.
measure: Use of Extracorporeal Circulation (ECMO)
time frame: 1 month
description: need to use ECMO to better oxygenate the lungs and heart. Yes / No categorical and dichotomous variable.
measure: Renal replacement therapy (dialysis)
time frame: 1 month
description: need for dialysis (peritoneal or hemodialysis) as a complementary treatment for COVID-19. Yes / No categorical and dichotomous variable.
measure: Blood products
time frame: 1 month
description: need for blood products as a complementary treatment to COVID-19. Yes / No categorical and dichotomous variable.
measure: Other therapeutic modalities
time frame: 1 month
description: need for other complementary treatments of COVID-19. Yes / No categorical and dichotomous variable.
measure: Amniotic fluid in the last ultrasound examination
time frame: 14 days
description: defined by the amniotic fluid index (ILA) or the largest pocket, according to the experience of the ultrasonographer. The ILA will be measured in cm, being defined as the sum of the largest pockets of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 8.0 and 18.0cm), decreased (between 7.9 and 5.0cm), moderate oligohydramnios (between 4.9 and 3.0cm), severe oligohydramnios (<3 , 0cm), increased (between 18.1 and 24cm) and polyhydramnios (ILA> 24cm) (81.82). The largest pocket will also be measured in cm, being defined as the measure of the largest pocket of amniotic fluid in the four quadrants of the maternal abdomen. It will be categorized into: normal (between 3.0 and 8.0cm), decreased (between 2.9 and 2.0cm), moderate oligoamine (between 1.9 and 1.0cm), severe oligoamine (<1.0cm), increased (ILA between 8.1 and 12.0cm) and polyhydramnios (ILA> 12.0cm).
measure: Fetal growth restriction
time frame: 14 days
description: defined by the Delphi procedure 2016 . Yes / No categorical and dichotomous variable.
measure: Small fetus for gestational age (SGA)
time frame: 14 days
description: defined when the estimated fetal weight is <10pct for gestational age and does not meet the criteria for IUGR. Yes / No categorical and dichotomous variable.
measure: Presence of fetal morphological changes
time frame: 1 month
description: presence of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound. Yes / No categorical and dichotomous variable.
measure: Fetal morphological changes
time frame: 1 month
description: description of any abnormalities in fetal formation, major defects, or presence of minor changes diagnosed by ultrasound.
measure: Frequency of fetal tachycardia (FFT)
time frame: 1 month
description: increased FFT diagnosed by ultrasound or Doppler sonar, with sinus rhythm, when greater than 160bpm. Yes / No categorical and dichotomous variable.
measure: Doppler velocimetry parameters in the last ultrasound examination
time frame: 1 month
description: from the pulsatility index (PI), which is automatically calculated by the ultrasound device, using the formula: systolic peak minus the diastolic peak divided by the average speed.
measure: Gestational age of amniocentesis
time frame: 1 month
description: gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound of amniocentesis. Numerical and discrete variable.
measure: Amniocentesis indications
time frame: 1 month
description: indication for amniocentesis, due to COVID-19 or another cause.
measure: Result of amniocentesis for COVID19
time frame: 1 month
description: result of RT-PCR for COVID-19, in amniotic fluid, according to the usual technique, being categorized as positive, negative and indeterminate.
measure: Amniocentesis cytokines
time frame: 1 month
description: substances capable of modulating the cellular response of several cells, such as interleukins IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in amniotic fluid, in pg / ml, from the beginning of the flu syndrome or COVID-19 , and in the period of the syndrome. Numeric and continuous variable (for each cytokine).
measure: Need for hospitalization due to obstetric causes
time frame: 1 month
description: need for hospitalization due to some comorbidity or obstetric complications. Yes / No categorical and dichotomous variable.
measure: Maternal hospital stay
time frame: 1 month
description: total hospital stay for any comorbidity or obstetric complications. Numerical and discrete variable.
measure: Obesity
time frame: 1 month
description: calculated based on the last BMI (weight [kg] / height [m] 2), by gestational age, using the curve by Atalah et al. Yes / No categorical and dichotomous variable.
measure: Chronic arterial hypertension (CAH)
time frame: 1 month
description: defined as blood pressure (BP) greater than or equal to 140 / 90mmHg, diagnosed before pregnancy, or before the 20th week of pregnancy . Yes / No categorical and dichotomous variable.
measure: Superimposed preeclampsia
time frame: 1 month
description: defined as CAH associated with signs of severity . Yes / No categorical and dichotomous variable.
measure: Gestational hypertension
time frame: 1 month
description: defined as BP greater than or equal to 140 / 90mmHg, diagnosed above the 20th week of pregnancy, with no signs of severity or proteinuria . Yes / No categorical and dichotomous variable.
measure: Pre-eclampsia
time frame: 1 month
description: defined as BP greater than or equal to 140 / 90mmHg, above the 20th week of pregnancy, associated with proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3 ), or target organ dysfunction, which can be categorized as severe and non-severe . Yes / No categorical and dichotomous variable.
measure: Eclampsia
time frame: 1 month
description: defined as BP greater than or equal to 140 / 90mmHg above the 20th week of gestation, in the presence of proteinuria (greater than 300mg / dl in 24-hour urine or tape, or protein / creatinine ratio greater than 0.3), associated with seizures. Yes / No categorical and dichotomous variable.
measure: HELLP syndrome
time frame: 1 month
description: defined by the presence of hemolysis, elevated liver enzymes, decreased platelets (below 100,000 / L), elevated TGO / TGP (above 70UI / L) . Yes / No categorical and dichotomous variable.
measure: Clinical diabetes
time frame: 1 month
description: defined by the presence of one of the criteria: HbA1C ≥ 6.5% or fasting blood glucose ≥ 126mg / dl - the test should be repeated - or random blood glucose> 200mg / dl, associated with symptoms of diabetes , depending on diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.
measure: Gestational diabetes
time frame: 1 month
description: defined by the presence of at least one of the criteria after an oral glucose tolerance test (TOTG) performed between the 24th and 28th weeks of gestation: fasting glucose ≥ 92mg / dl, or ≥ 180mg / dl (after one hour), or ≥ 153mg / dl (after two hours) , according to the diagnosis declared by the patient and recorded in medical records. Yes / No categorical and dichotomous variable.
measure: Premature rupture of membranes
time frame: 1 month
description: spontaneous rupture of the membranes, diagnosed by anamnesis and clinical examination of the pregnant woman, before the start of labor. Yes / No categorical and dichotomous variable.
measure: Premature labor
time frame: 1 month
description: defined as the spontaneous triggering of labor before term (<37 weeks), when there were above three contractions in 30 minutes and cervical alteration, according to clinical and obstetric evaluation. Yes / No categorical and dichotomous variable.
measure: Placenta previa
time frame: 1 month
description: define when the placental insertion is low, close to the cervix, regardless of its classification (total, partial and marginal), according to ultrasound report. Yes / No categorical and dichotomous variable.
measure: Abortion
time frame: 1 month
description: termination of pregnancy before the 22nd week and / or below 500 g, gestational age preferable, provided it is reliable, regardless of whether it is spontaneous or provoked. Yes / No categorical and dichotomous variable.
measure: Normally inserted placental abruption
time frame: 1 month
description: defined as vaginal bleeding and / or uterine hypertonia, leading to emergency delivery, with evidence of retroplacental hematoma in the postpartum period. Yes / No categorical and dichotomous variable.
measure: Maternal urinary tract infection
time frame: 1 month
description: defined when urine culture is positive for any microorganism, and treatment has been started, regardless of symptoms. Yes / No categorical and dichotomous variable.
measure: Maternal heart disease
time frame: 1 month
description: presence of any congenital or acquired maternal heart disease, according to the patient's information, or diagnosed during hospitalization. Yes / No categorical and dichotomous variable.
measure: Bronchial asthma
time frame: 1 month
description: as reported by the patient and / or described in the medical record presenting the diagnosis of asthma. Yes / No categorical and dichotomous variable.
measure: Chronic obstructive pulmonary disease (COPD)
time frame: 1 month
description: as reported by the patient and / or described in the medical record presenting the diagnosis of COPD. Yes / No categorical and dichotomous variable.
measure: Cerebrovascular disease
time frame: 1 month
description: as reported by the patient and / or described in the chart that presents the diagnosis of cerebrovascular disease. Yes / No categorical and dichotomous variable.
measure: Chronic kidney injury
time frame: 1 month
description: as reported by the patient and / or described in the chart that presents the diagnosis of CRL. Yes / No categorical and dichotomous variable.
measure: Immunosuppression
time frame: 1 month
description: as reported by the patient and / or described in the chart that presents the diagnosis of immunosuppressive disease or use immunosuppressive medication. Categorical and dichotomous Yes / No type.
measure: Maternal pneumonia
time frame: 1 month
description: presence of the flu syndrome associated with laboratory changes, such as leukocytosis or leukopenia, and radiological, such as localized or diffuse interstitial infiltrate, or presence of a condensation area, as diagnosed by the attending physician. Yes / No categorical and dichotomous variable.
measure: Maternal sepsis
time frame: 1 month
description: life-threatening organ dysfunction resulting from an unregulated response by the body to an infection. Yes / No categorical and dichotomous variable.
measure: Septic shock
time frame: 1 month
description: defined as a situation of sepsis, associated with signs of hypoperfusion, with fluid-refractory hypotension and requiring vasopressor therapy (Lactate> 2 mmol / L). Yes / No categorical and dichotomous variable.
measure: Severe acute respiratory syndrome (SARS)
time frame: 1 month
description: flu-like syndrome (fever, cough, dyspnoea and other nonspecific), accompanied by oxygen saturation <95% (SatO2), respiratory distress or tachypnea, hypotension and worsening of the clinical conditions of the underlying disease. Yes / No categorical and dichotomous variable.
measure: Postpartum hemorrhage
time frame: 14 days
description: increased postpartum bleeding, according to the assessment of the attending physician, requiring some maneuver or therapy for control. Yes / No categorical and dichotomous variable.
measure: Infection of the operative site
time frame: 14 days
description: exit of purulent secretion by the surgical scar, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.
measure: Endometritis
time frame: 14 days
description: characterized by the discharge of purulent secretion from the uterine cervix, remaining dilated, with an unpleasant odor and fever for a minimum of two consecutive days, excluding the first 24 hours, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.
measure: Peritonitis
time frame: 14 days
description: characterized by abdominal pain, with compatible image examination, according to the assessment of the attending physician. Categorical and dichotomous Yes / No type.
measure: Need for postpartum hysterectomy
time frame: 1 month
description: removal of the uterus, for any indication, according to the assessment of the attending physician. Yes / No categorical and dichotomous variable.
measure: Type of delivery
time frame: 1 hour
description: defined as the type of delivery performed, categorized as normal, instrumental (vacuum or forceps) or cesarean delivery.
measure: Indication of cesarean section
time frame: 1 hour
description: if a cesarean section was performed, insert the indication that the attending physicians described, which can be later modified, according to the medical record evaluation by the researchers. The main indications are: dystocias, including cephalopelvic disproportion, macrosomia, impaired fetal vitality, placenta previa, cord prolapse, placental abruption, among others.
measure: Gestational age at birth
time frame: 1 hour
description: gestational age at birth, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the amniocentesis. Numerical and discrete variable.
measure: Use of labor analgesia
time frame: 4 hours
description: use of pharmacological labor analgesia, as indicated by the attending physician and declared in medical records. Yes / No categorical and dichotomous variable.
measure: Type of anesthesia for cesarean section
time frame: 1 hour
description: method of anesthesia for performing cesarean section, categorized into spinal anesthesia, epidural and general anesthesia.
measure: Antenatal corticosteroid therapy (pulmonary maturity)
time frame: 14 days
description: as noted in the medical records, referring to the complete course of betamethasone (12mg two doses in a 24h interval) or dexamethasone (6mg 12 / 12h, for two days), incomplete course, not taking corticosteroids or without indication for accelerating fetal lung maturity.
measure: Use of maternal magnesium sulphate (prophylaxis of the newborn and / or prevention of eclampsia)
time frame: 32 weeks
description: as noted in the medical record, magnesium sulphate for neuroprotection, before delivery and until the 32nd week of pregnancy, being categorized as complete course (performance of attack and first stage of magnesium sulfate before delivery), incomplete, not performed or without indication.
measure: Maternal prophylactic antibiotic therapy (prophylaxis of neonatal sepsis)
time frame: 14 days
description: as noted in the medical records, referring to the use of the prophylactic regimen of crystalline penicillin to prevent neonatal infection with group B Streptococcus, being categorized as complete (completion of at least two phases) crystalline penicillin before delivery), incomplete, not performed or without indication.
measure: Hospital discharge when pregnant
time frame: 1 month
description: when the pregnant patient was admitted and discharged while pregnant. Yes / No categorical and dichotomous variable.
measure: Hospital discharge when puerperal
time frame: 1 month
description: when the pregnant or puerperal patient has been admitted and discharged in the puerperal state. Yes / No categorical and dichotomous variable.
measure: Maternal death when pregnant
time frame: 1 month
description: when maternal death occurs with the pregnant patient. Categorical and dichotomous Yes / No type.
measure: Maternal death when puerperal
time frame: 45 days
description: when maternal death occurs with the patient in the puerperal state. Categorical and dichotomous Yes / No type.
measure: Fetal death
time frame: 10 hours
description: birth of a fetus without vitality. Yes / No categorical and dichotomous variable.
measure: Perinatal death
time frame: 27 days
description: fetal or neonatal death (up to and including the 27th day of life). Yes / No categorical and dichotomous variable.
measure: Birth weight
time frame: 1 hour
description: as measured on a standard scale, in the delivery room, in grams, and recorded in medical records. Numerical and discrete variable.
measure: Adequacy of birth weight
time frame: 1 hour
description: classification of birth weight, according to gestational age, being categorized as: small for gestational age (SGA), when <10th pct; suitable for gestational age (AGA), when between 10º pct and 90º pct; and great for gestational age (GIG), when> 90º pct.
measure: Apgar scores in the first minute
time frame: 1 minute
description: as calculated by the classic Apgar score , in the first minute of birth, recorded in medical records, which can be later categorized. Numerical and discrete.
measure: Apgar scores in the fifth minute
time frame: 5 minutes
description: as calculated by the classic Apgar score, in the fifth minute of birth, recorded in medical records, which can be further categorized. Numerical and discrete variable.
measure: Neonatal ICU admission
time frame: 1 hour
description: defined as the newborn's stay in the neonatal intensive care unit after delivery, to perform any procedure. Yes / No categorical and dichotomous variable.
measure: Need for neonatal resuscitation
time frame: 27 days
description: defined as the need for resuscitation maneuvers, performed on the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.
measure: Need for neonatal mechanical ventilation
time frame: 27 days
description: defined as the need for assisted mechanical ventilation, provided to the newborn, in the delivery room or until the 27th day after delivery. Yes / No categorical and dichotomous variable.
measure: Neonatal nasal catheter
time frame: 27 days
description: need for a neonatal nasal catheter to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
measure: Neonatal Continuous Positive Airway Pressure (CPAP) mask
time frame: 27 days
description: need for neonatal CPAP to maintain normal oxygen saturation. Yes / No categorical and dichotomous variable.
measure: Neonatal hypothermia
time frame: 27 days
description: defined when the axillary temperature is less than or equal to 35ºC, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
measure: Neonatal hypoglycemia
time frame: 27 days
description: defined as peripheral blood glucose below 40mg / dl, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
measure: Neonatal infection
time frame: 27 days
description: defined as any neonatal infection diagnosed as noted in the medical record by neonatal care. Yes / No categorical and dichotomous variable.
measure: Chorioamnionitis
time frame: 27 days
description: defined as the infection of the amniotic cavity, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
measure: Neonatal respiratory distress modality
time frame: 1 month
description: defined as newborn's respiratory distress (RDS), transient tachypnea of the newborn (NRT) or absent respiratory distress, as noted in the medical record for neonatal care.
measure: Neonatal congenital infection (TORCHS)
time frame: 1 month
description: defined as any congenital infection confirmed at birth, based on fetal PCR, neonatal examination or maternal serology, as noted in the medical record for neonatal care. Yes / No categorical and dichotomous variable.
measure: Congenital malformation
time frame: 1 month
description: defined as any fetal congenital malformation present, as noted in medical records by neonatal care. Yes / No categorical and dichotomous variable.
measure: Breastfeeding
time frame: 1 month
description: exclusive breastfeeding, during hospitalization, by natural method or pasteurized breast milk. Yes / No categorical and dichotomous variable.
measure: Cord ligation
time frame: 10 minutes
description: can be divided into early, when performed in less than three minutes, and timely, when between three to five minutes. Categorical and dichotomous variable.
measure: Skin-to-skin contact
time frame: 1 hour
description: as early contact was made between the mother and the baby, early, still in the delivery room. Yes / No categorical and dichotomous variable.
measure: Breastfeeding in the delivery room
time frame: 1 hour
description: according to breastfeeding, early, still in the delivery room. Yes / No categorical and dichotomous variable.
measure: Days of life of the newborn's diagnostic suspicion
time frame: 1 month
description: days of life of the newborn until the newborn's diagnostic suspicion. Numerical and discrete variable.
measure: Result of the Polymerase Chain Reaction - Real Time (RT-PCR) for neonatal COVID-19 in diagnosis, at 6 months, 12 months and 24 months
time frame: 6 months, 12 months and 24 months
description: result of RT-PCR in the diagnosis of COVID-19, through the blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.
measure: Result of Polymerase Chain Reaction - Real Time (RT-PCR) for the differential diagnosis of neonatal respiratory syndrome (viral panel)
time frame: 6 months, 12 months and 24 months
description: result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.
measure: Neonatal viral panel in the diagnosis, at 6 months, 12 months and 24 months
time frame: 6 months, 12 months and 24 months
description: result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.
measure: Neonatal cytokines
time frame: 6 months, 12 months and 24 months
description: substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL -4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine)
measure: Neonatal IgM COVID-19
time frame: 5 days
description: result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according with the reference values of each serological kit, performed after the 5th day of signs and symptoms.
measure: IgA COVID-19 neonatal serial
time frame: 5 days
description: result of IgA COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.
measure: Serial neonatal IgG COVID-19
time frame: 14 days
description: result of IgG COVID-19 serology, through neonatal blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 14th day of signs and symptoms. Numeric and continuous variable.
measure: Neonatal reinfection
time frame: 14 days
description: after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.
measure: Hemoglobin from neonatal diagnosis
time frame: 14 days
description: value of the first hemoglobin measured in neonatal blood, in g / dL, from the suspicion of the diagnosis by COVID-19. Numeric and continuous variable.
measure: Diagnostic neonatal bleeding time (BT)
time frame: 1 month
description: value of the first BT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Diagnostic neonatal clotting time (CT)
time frame: 1 month
description: value of the first CT measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Urea from neonatal diagnosis
time frame: 1 month
description: value of the first urea measured in neonatal blood, in mg / dL, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Creatinine from neonatal diagnosis
time frame: 1 month
description: value of the first creatinine measured in neonatal blood, in mg / dL, based on the suspected diagnosis by COVID-19. Numerical and discrete variable.
measure: Transaminases of the neonatal diagnosis
time frame: 1 month
description: defined as aspartate aminotransferase or glutamic-oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase, based on the suspicion of the diagnosis by COVID-19.
measure: Blood culture of the neonatal diagnosis
time frame: 1 month
description: result of the first blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: Uroculture of neonatal diagnosis
time frame: 1 month
description: result of the first urine culture, based on the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: IgM COVID-19 - worst neonatal result
time frame: 5 days
description: worst result of IgM COVID-19 serology, using neonatal blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate , according to the reference values of each serological kit, performed after the 5th day of signs and symptoms.
measure: Neonatal IgG COVID-19 - worst serial result
time frame: 14 days
description: worst result of IgG COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 14th day of signs and symptoms. Numeric and continuous variable.
measure: Cytokines - worst neonatal result
time frame: 14 days
description: worst result of cytokines, substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12 , IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in neonatal blood, in pg / ml, from suspected diagnosis. Numeric and continuous variable (for each cytokine).
measure: Day of the worst blood count result from the beginning of the suspected diagnosis by COVID-19
time frame: 1 month
description: day of the worst blood count result, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Day of the worst value of the neonatal coagulogram from the suspicion of the diagnosis by COVID-19
time frame: 1 month
description: day of the realization of the worst value of the coagulogram, from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Bleeding time - worst neonatal result (BT)
time frame: 1 month
description: value of the worst BT result measured in neonatal blood, in seconds (s), from the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Urea - worst neonatal result
time frame: 1 month
description: value of the worst result of urea measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Creatinine - worst neonatal result
time frame: 1 month
description: value of the worst result of creatinine measured in neonatal blood, in mg / dL, based on the suspicion of the diagnosis by COVID-19. Numerical and discrete variable.
measure: Transaminases - worst neonatal result
time frame: 1 month
description: defined as the worst result of aspartate aminotransferase (AST) or glutamic oxalacetic transaminase and alanine aminotransferase or glutamic-pyruvic transaminase measurements, from the beginning of suspected COVID-19 diagnosis.
measure: Blood culture - worst neonatal result
time frame: 1 month
description: result of the worst blood culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: Uroculture - worst neonatal result
time frame: 1 month
description: result of the worst urine culture, from the suspicion of the diagnosis by COVID-19, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.
measure: Gasometry - worst neonatal result
time frame: 1 hour
description: defined as the worst result of measuring hydrogen potential, excess of bases, bicarbonate, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2) and oxygenation index, in neonatal arterial blood, from the beginning of suspected COVID-19 diagnosis.
measure: Result of RT-PCR of the placenta
time frame: 1 month
description: result of RT-PCR in the diagnosis of COVID-19, through the placenta, according to the usual technique, being categorized as positive, negative and indeterminate.
measure: Placental viral panel
time frame: 1 month
description: result of the RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through the placenta, according to the technique and kit used, categorized according to the virus found.
measure: Histopathological of the placenta
time frame: 1 month
description: result of the histopathological of the placenta, according to the usual technique.
measure: Result of RT-PCR in breast milk at diagnosis, at birth and with and at hospital discharge
time frame: 1 month
description: result of RT-PCR in the diagnosis of COVID-19, using breast milk, according to the usual technique, being categorized as positive, negative and indeterminate.
measure: Viral panel in breast milk
time frame: 1 month
description: result of RT-PCR of the viral panel in the differential diagnosis of respiratory syndrome, through breast milk, according to the technique and kit used, categorized according to the virus found.
measure: Presence of alteration of the neonatal chest radiography
time frame: 1 day
description: presence of any radiological alteration, described in a medical report. Yes / No categorical and dichotomous variable.
measure: Result of neonatal chest radiography
time frame: 1 day
description: description of any radiological changes, according to a medical report.
measure: Presence of alteration of the neonatal chest tomography
time frame: 1 day
description: presence of any alteration of the tomography, described in a medical report. Yes / No categorical and dichotomous variable.
measure: Result of neonatal chest tomography
time frame: 1 day
description: description of any alteration of the tomography, according to a medical report.
measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Head circumference
time frame: 6, 12 and 24 months
description: measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.
measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Weight
time frame: 6, 12 and 24 months
description: measured by the assistant pediatrician as noted on the prenatal card, in grams. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.
measure: Parameters for monitoring the growth of the newborn at 6, 12 and 24 months - Height
time frame: 6, 12 and 24 months
description: measured by the assistant pediatrician as noted on the prenatal card, in cm. It can later be categorized, according to the WHO gestational age curve, 2006. Continuous numerical variable.
measure: Development of the newborn up to 6 months
time frame: 6 months
description: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as adequate, when all are present, and inappropriate, if any of the situations is absent: the baby is firmer and already sits with support; he turns around and rolls from side to side; grabs toys like rings and rattles, holding tight and resisting if someone tries to take them out of your hand; and when he hears some noise, he turns his head to find where it comes from.
measure: Development of the newborn up to 12 months
time frame: 12 months
description: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inappropriate, if any of the situations is absent: the baby can stand up, leaning on furniture or with the help of a person; clap your hands, you can point with your finger what you want to catch and have fun saying goodbye; and you may be speaking a word or two like mom, pope, give.
measure: Development of the newborn up to 24 months
time frame: 24 months
description: as assessed by the responsible for the newborn and the assistant pediatrician and noted on the prenatal card. It will be considered as appropriate, when all are present, and inadequate, if any of the situations is absent: start to put two words together and speak simple phrases like "where's the cat?" or "milk not"; he demonstrates his own will, tests limits and speaks the word "no" a lot; climbs on chairs and sofas. Run, go up and down stairs, standing, with the help of an adult; can help to dress; and you can start to learn how to control pee and poop.
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
last name: LEILA KATZ, MD, PhD
role: Principal Investigator
affiliation: Instituto Materno Infantil Prof. Fernando Figueira
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto Materno Infantil Prof. Fernando Figueira
investigator full name: Leila Katz
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Severe Acute Respiratory Syndrome