<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/NCT04416373</url>
  </required_header>
  <id_info>
    <org_study_id>COVID&amp;PREG</org_study_id>
    <nct_id>NCT04416373</nct_id>
  </id_info>
  <brief_title>COVID-19 and Pregnancy Outcomes</brief_title>
  <acronym>COVID&amp;PREG</acronym>
  <official_title>COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Nova de Lisboa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Nova de Lisboa</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>
      This is a multicenter prospective study that aims to investigate the clinical impact of&#xD;
      SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data&#xD;
      will be collected in Portuguese maternities that agreed to collaborate in this study.&#xD;
&#xD;
      Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for&#xD;
      SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age,&#xD;
      comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests,&#xD;
      therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy&#xD;
      outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal&#xD;
      outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies&#xD;
      will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 22, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SARS-CoV-2 Neonatal Infection</measure>
    <time_frame>7 days</time_frame>
    <description>Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perinatal mortality</measure>
    <time_frame>35 weeks</time_frame>
    <description>stillbirths and deaths in the first week of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU maternal admission</measure>
    <time_frame>35 weeks</time_frame>
    <description>maternal ICU admission due to COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5 minute Apgar Score &lt; 7</measure>
    <time_frame>1 day</time_frame>
    <description>Newborn 5 minute Apgar Score &lt; 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm labour</measure>
    <time_frame>35 weeks</time_frame>
    <description>Delivery between 24 and 36 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PPROM</measure>
    <time_frame>35 weeks</time_frame>
    <description>Preterm premature rupture of the membranes between 24 and 36 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage</measure>
    <time_frame>14 weeks</time_frame>
    <description>spontaneous pregnancy loss before 24 weeks</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>Pregnancy Complications</condition>
  <condition>Vertical Transmission of Infectious Disease</condition>
  <condition>Breastfeeding</condition>
  <condition>Neonatal Infection</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>RT PCR SARS-CoV-2</intervention_name>
    <description>Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples</description>
    <other_name>SARS-COV-2 Serologic test</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women infected with Sars-Cov-2 from 6 to 41 weeks.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Pregnant women infected with Sars-Cov-2. Delivery at Portuguese&#xD;
        maternities.&#xD;
&#xD;
        Exclusion Criteria: RT PCR SARS-CoV-2 negative.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nadia Charepe, MD,MSc</last_name>
    <phone>00351213184000</phone>
    <email>nadia.charepe@chlc.min-saude.pt</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexandra Queirós, MD</last_name>
    <phone>00351213184000</phone>
    <email>alexandra.queiros@nms.unl.pt</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nova Medical School - UNL</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nadia Charepe, MSc, MD</last_name>
      <phone>00351213184000</phone>
      <email>nadia.charepe@chlc.min-saude.pt</email>
    </contact>
    <contact_backup>
      <last_name>Alexandra Queirós, MD</last_name>
      <phone>00351213184000</phone>
      <email>alexandra.queiros@nms.unl.pt</email>
    </contact_backup>
    <investigator>
      <last_name>Ana M Campos, PhD,MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nadia Charepe, MSc, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexandra S Queiros, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria J Alves, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Teresa Ventura, PhD,MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04416373
org study id: COVID&PREG
nct id: NCT04416373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicenter prospective study that aims to investigate the clinical impact of
      SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.
This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data
      will be collected in Portuguese maternities that agreed to collaborate in this study.

      Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for
      SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age,
      comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests,
      therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy
      outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal
      outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies
      will be evaluated.
observational model: Cohort
time perspective: Prospective
measure: SARS-CoV-2 Neonatal Infection
time frame: 7 days
description: Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
measure: Perinatal mortality
time frame: 35 weeks
description: stillbirths and deaths in the first week of life
measure: ICU maternal admission
time frame: 35 weeks
description: maternal ICU admission due to COVID-19
measure: 5 minute Apgar Score < 7
time frame: 1 day
description: Newborn 5 minute Apgar Score < 7
measure: Preterm labour
time frame: 35 weeks
description: Delivery between 24 and 36 weeks
measure: PPROM
time frame: 35 weeks
description: Preterm premature rupture of the membranes between 24 and 36 weeks
measure: Miscarriage
time frame: 14 weeks
description: spontaneous pregnancy loss before 24 weeks
intervention type: Diagnostic Test
intervention name: RT PCR SARS-CoV-2
description: Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
other name: SARS-COV-2 Serologic test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 55 Years
healthy volunteers: No
last name: Nadia Charepe, MD,MSc
phone: 00351213184000
email: nadia.charepe@chlc.min-saude.pt
last name: Alexandra Queirós, MD
phone: 00351213184000
email: alexandra.queiros@nms.unl.pt
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Portugal
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Coronavirus Infections
mesh term: Pregnancy Complications
sharing ipd: Undecided