<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/NCT04402918</url>
  </required_header>
  <id_info>
    <org_study_id>2020/500</org_study_id>
    <nct_id>NCT04402918</nct_id>
  </id_info>
  <brief_title>Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy</brief_title>
  <acronym>TRANSCOVID</acronym>
  <official_title>Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      The study evaluates the distribution of immunological and virological profiles of newborns&#xD;
      patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2020</start_date>
  <completion_date type="Actual">August 2, 2021</completion_date>
  <primary_completion_date type="Actual">May 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vrological profile of newborns.</measure>
    <time_frame>day of delivery</time_frame>
    <description>Describe the virological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : Covid+ or covid-</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunological profile of newborns.</measure>
    <time_frame>day of delivery</time_frame>
    <description>Describe the immunological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : IgG and/or IgM or absence</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>pregnancy patients diagnosed with SARS Cov2 during pregnancy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Delivery day biological samples from the mother and the newborn will be performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>biological samples day of delivery</intervention_name>
    <description>mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration</description>
    <arm_group_label>pregnancy patients diagnosed with SARS Cov2 during pregnancy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  diagnosed with Sars Cov-2 during pregnancy&#xD;
&#xD;
          -  singleton or twin pregnancy&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  virological or serological samples not done the day of delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Besancon</name>
      <address>
        <city>Besancon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04402918
org study id: 2020/500
nct id: NCT04402918
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluates the distribution of immunological and virological profiles of newborns
      patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Vrological profile of newborns.
time frame: day of delivery
description: Describe the virological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : Covid+ or covid-
measure: Immunological profile of newborns.
time frame: day of delivery
description: Describe the immunological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : IgG and/or IgM or absence
arm group label: pregnancy patients diagnosed with SARS Cov2 during pregnancy
arm group type: Other
description: Delivery day biological samples from the mother and the newborn will be performed
intervention type: Diagnostic Test
intervention name: biological samples day of delivery
description: mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration
arm group label: pregnancy patients diagnosed with SARS Cov2 during pregnancy
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No