<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/NCT04492449</url>
  </required_header>
  <id_info>
    <org_study_id>FOBpregnat</org_study_id>
    <nct_id>NCT04492449</nct_id>
  </id_info>
  <brief_title>Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to COVID-19 Infection</brief_title>
  <acronym>(COVID-19</acronym>
  <official_title>Evaluation of Systemic and Oral Conditions of Pregnant Women and Their Babies, With Exposure to Coronavirus SARS-CoV-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maria Aparecida de Andrade Moreira Machado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thais Marchini de Oliveira Valarelli</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This research aims to investigate the incidence, clinical condition, mode of transmission and&#xD;
      laboratory data of women and their babies, who were exposed to COVID-19 infection during&#xD;
      pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will&#xD;
      be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of&#xD;
      prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess&#xD;
      periodontal condition and quality of life before and after delivery of women with excess&#xD;
      weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the&#xD;
      proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd&#xD;
      trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence&#xD;
      of congenital syndrome in babies associated with the presumed maternal infection with&#xD;
      SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical&#xD;
      examination, being a group with congenital malformations and their respective controls and an&#xD;
      interview with the mother was carried out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study will be included pregnant women who are in the third trimester of pregnancy&#xD;
      (from the 27th gestational week), aged 18-40 years, with regular follow-up with the&#xD;
      obstetrician and who present adequate systemic health during pregnancy, without the need for&#xD;
      absolute rest. In subprojects 1 and 2, pregnant women who tested positive for IgM and IgG&#xD;
      serology will be evaluated. Pregnant women who test positive (n = 60) and pregnant women who&#xD;
      test negative (n = 60) for coronavirus sars-cov-2 will be selected, making a total of 120&#xD;
      pregnant women. In project 1 the sample will be divided into 4 groups of pregnant women: GOC-&#xD;
      with excessive weight gain and with COVID19 (n = 30), GOSC- without excessive weight gain and&#xD;
      COVID19, GNC- without excessive weight gain and with COVID19 (n = 30) and GNSC- without&#xD;
      excessive weight gain and without COVID19 (n = 30). For subproject 2 that will have proteomic&#xD;
      analysis, the number of 10 patients for each group (GOC, GOSC, GNC and GNSC) will be adopted&#xD;
      according to previous protocols for saliva proteomic analysis. Subprojects 3 and 4 will&#xD;
      consist of babies, to identify possible congenital changes during the fetal period. In&#xD;
      subproject 3, the 120 babies of the pregnant women participating in the study will be divided&#xD;
      into BC (n = 60) and BSC (n = 60), which will be evaluated for the occurrence of the&#xD;
      congenital syndrome associated with the presumed maternal infection by coronavirus sars-&#xD;
      cov-2. In project 4, the sample will consist of 20 babies with congenital malformations for&#xD;
      the case group (BM) and 20 control babies without congenital malformations (BSM), exposed to&#xD;
      COVID19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 2022</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontal status</measure>
    <time_frame>Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing &gt;3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.</time_frame>
    <description>Probing pocket depth (PPD) and clinical attachment level (CAL) will be assessed. The PPD will be measured from the free gingival margin to the bottom of the periodontal pocket, and CAL will be measured from the cementoenamel junction to the base of the periodontal pocket, at six dental sites (mesial buccal/lingual, cervical buccal/lingual, distal buccal/lingual) excluding the third molars.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life of pregnants</measure>
    <time_frame>Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 &lt; OHIP≤ 9); moderate impact (9 &lt; OHIP≤ 18); and high impact (18 &lt; OHIP≤ 28).</time_frame>
    <description>Quality of live will be investigated by a questionnaire (OHIP-14), the impact of oral health on patients' quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maternal infection</measure>
    <time_frame>Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.</time_frame>
    <description>IgM and IgG serology test for COVID19</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Exposure During Pregnancy</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>Obese pregnants group</arm_group_label>
    <description>Obese pregnants exposure of coronavirus infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal pregnants group</arm_group_label>
    <description>Normal pregnants exposure of coronavirus infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>children with congenital malformations</arm_group_label>
    <description>Child with congenital malformations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>children without congenital malformations</arm_group_label>
    <description>Child without congenital malformations</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>congenital malformation</intervention_name>
    <description>congenital malformation</description>
    <arm_group_label>children with congenital malformations</arm_group_label>
    <arm_group_label>children without congenital malformations</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Projects: 1. The sample will be of pregnant women: GOC- with excessive weight gain and with&#xD;
        COVID19 (n = 30), GOSC- without excessive weight gain and COVID19, GNC- without excessive&#xD;
        weight gain and with COVID19 (n = 30 ) and GNSC- without excessive weight gain and without&#xD;
        COVID19 (n = 30); 2. The proteomic analysis the sample will be 10 patients for each group&#xD;
        (GOC, GOSC, GNC and GNSC); 3. The 120 babies of the pregnant women participating in the&#xD;
        study will be divided into BC (n = 60) and BSC (n = 60), which will be evaluated for the&#xD;
        occurrence of the congenital syndrome associated with the presumed maternal COVID-19&#xD;
        infection; 4. 20 babies with congenital malformations for the case group (BM) and 20&#xD;
        control babies without congenital malformations (BSM), exposed to COVID19.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for pregnant will be in the third trimester of pregnancy (from the 27th&#xD;
        gestational week), aged 18-40 years, with regular follow-up with the obstetrician and who&#xD;
        present adequate systemic health during pregnancy, without the need for absolute rest.&#xD;
&#xD;
        Exclusion Criteria criteria for pregnant will be patients with neuromotor weakness,&#xD;
        hypertension and diabetes mellitus prior to pregnancy, malnutrition (BMI &lt;18.50 kg/m2),&#xD;
        overweight (BMI between 25.00 kg/m2 and 29.99 kg/m2), under antibiotic use or any&#xD;
        medication that may interfere with periodontal condition and users of&#xD;
        alcohol/tobacco/illicit drugs.&#xD;
&#xD;
        Inclusion criteria for babies will be mothers having tested COVID-19 positive and mothers&#xD;
        having tested COVID-19 negative in serological tests, to the BC group and the BSC group,&#xD;
        respectively.&#xD;
&#xD;
        Exclusion criteria for babies will be after measuring the measurements, exams and&#xD;
        eligibility criteria, they are not eligible for coronavirus contamination during the fetal&#xD;
        period.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Liu D, Li L, Wu X, Zheng D, Wang J, Yang L, Zheng C. Pregnancy and Perinatal Outcomes of Women With Coronavirus Disease (COVID-19) Pneumonia: A Preliminary Analysis. AJR Am J Roentgenol. 2020 Jul;215(1):127-132. doi: 10.2214/AJR.20.23072. Epub 2020 Mar 18. Erratum In: AJR Am J Roentgenol. 2020 Jul;215(1):262.</citation>
    <PMID>32186894</PMID>
  </results_reference>
  <results_reference>
    <citation>Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016 Jan;47(1):6-7. doi: 10.1002/uog.15831. No abstract available.</citation>
    <PMID>26731034</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Silvia Helena de Carvalho Sales Peres</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>pregnant</keyword>
  <keyword>child</keyword>
  <keyword>Coronavirus Infections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04492449
org study id: FOBpregnat
nct id: NCT04492449
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research aims to investigate the incidence, clinical condition, mode of transmission and
      laboratory data of women and their babies, who were exposed to COVID-19 infection during
      pregnancy. This project will consist of 4 subprojects, being that Subprojects 1 and 2, will
      be of the observational, longitudinal type of prospective Cohort; Subproject 3 will be of
      prevalence; Subproject 4 will be case-control. Subproject 1- This study aims to assess
      periodontal condition and quality of life before and after delivery of women with excess
      weight gain or not, with exposure to coronavirus-sars-cov2. Subproject 2- Identify the
      proteins differentially expressed in saliva associated with COVID-19 infection during the 3rd
      trimester of pregnancy in obese and eutrophic patients. Subproject 3- Assess the prevalence
      of congenital syndrome in babies associated with the presumed maternal infection with
      SARS-CoV-2. Subproject 4- Case-control study in which newborns are submitted to clinical
      examination, being a group with congenital malformations and their respective controls and an
      interview with the mother was carried out.
The present study will be included pregnant women who are in the third trimester of pregnancy
      (from the 27th gestational week), aged 18-40 years, with regular follow-up with the
      obstetrician and who present adequate systemic health during pregnancy, without the need for
      absolute rest. In subprojects 1 and 2, pregnant women who tested positive for IgM and IgG
      serology will be evaluated. Pregnant women who test positive (n = 60) and pregnant women who
      test negative (n = 60) for coronavirus sars-cov-2 will be selected, making a total of 120
      pregnant women. In project 1 the sample will be divided into 4 groups of pregnant women: GOC-
      with excessive weight gain and with COVID19 (n = 30), GOSC- without excessive weight gain and
      COVID19, GNC- without excessive weight gain and with COVID19 (n = 30) and GNSC- without
      excessive weight gain and without COVID19 (n = 30). For subproject 2 that will have proteomic
      analysis, the number of 10 patients for each group (GOC, GOSC, GNC and GNSC) will be adopted
      according to previous protocols for saliva proteomic analysis. Subprojects 3 and 4 will
      consist of babies, to identify possible congenital changes during the fetal period. In
      subproject 3, the 120 babies of the pregnant women participating in the study will be divided
      into BC (n = 60) and BSC (n = 60), which will be evaluated for the occurrence of the
      congenital syndrome associated with the presumed maternal infection by coronavirus sars-
      cov-2. In project 4, the sample will consist of 20 babies with congenital malformations for
      the case group (BM) and 20 control babies without congenital malformations (BSM), exposed to
      COVID19.
observational model: Other
time perspective: Other
measure: Periodontal status
time frame: Interdental CAL is detectable at ≥2 non-adjacent teeth, or buccal CAL ≥3 mm with pocketing >3 mm is detectable at ≥2 teeth. After, periodontitis will be classified in stages I, II, III and IV of periodontitis.
description: Probing pocket depth (PPD) and clinical attachment level (CAL) will be assessed. The PPD will be measured from the free gingival margin to the bottom of the periodontal pocket, and CAL will be measured from the cementoenamel junction to the base of the periodontal pocket, at six dental sites (mesial buccal/lingual, cervical buccal/lingual, distal buccal/lingual) excluding the third molars.
measure: Quality of life of pregnants
time frame: Subjects will be asked how often (0=never, 1=rarely, 2=occasionally, 3=often, and 4=very often) experienced impacts. Scores will be: no impact (0); low impact (0 < OHIP≤ 9); moderate impact (9 < OHIP≤ 18); and high impact (18 < OHIP≤ 28).
description: Quality of live will be investigated by a questionnaire (OHIP-14), the impact of oral health on patients' quality of life.
measure: Maternal infection
time frame: Serological tests for IgG and IgM, considering positive IgM means that she has already been exposed and is in the active phase of the disease and, positive IgG indicates that the person has antibodies work as a protection.
description: IgM and IgG serology test for COVID19
arm group label: Obese pregnants group
description: Obese pregnants exposure of coronavirus infection.
arm group label: Normal pregnants group
description: Normal pregnants exposure of coronavirus infection.
arm group label: children with congenital malformations
description: Child with congenital malformations
arm group label: children without congenital malformations
description: Child without congenital malformations
intervention type: Other
intervention name: congenital malformation
description: congenital malformation
arm group label: children with congenital malformations
arm group label: children without congenital malformations
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Liu D, Li L, Wu X, Zheng D, Wang J, Yang L, Zheng C. Pregnancy and Perinatal Outcomes of Women With Coronavirus Disease (COVID-19) Pneumonia: A Preliminary Analysis. AJR Am J Roentgenol. 2020 Jul;215(1):127-132. doi: 10.2214/AJR.20.23072. Epub 2020 Mar 18. Erratum In: AJR Am J Roentgenol. 2020 Jul;215(1):262.
PMID: 32186894
citation: Oliveira Melo AS, Malinger G, Ximenes R, Szejnfeld PO, Alves Sampaio S, Bispo de Filippis AM. Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound Obstet Gynecol. 2016 Jan;47(1):6-7. doi: 10.1002/uog.15831. No abstract available.
PMID: 26731034
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Silvia Helena de Carvalho Sales Peres
investigator title: Associate Professor
mesh term: Infections
mesh term: Coronavirus Infections
sharing ipd: No