Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy (TRANSCOVID)

August 2, 2021 updated by: Centre Hospitalier Universitaire de Besancon

Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • CHU Besançon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant woman
  • diagnosed with Sars Cov-2 during pregnancy
  • singleton or twin pregnancy
  • informed consent

Exclusion Criteria:

  • virological or serological samples not done the day of delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: pregnancy patients diagnosed with SARS Cov2 during pregnancy
Delivery day biological samples from the mother and the newborn will be performed
Diagnostic test: biological samples day of delivery
mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vrological profile of newborns.
Time Frame: day of delivery
Describe the virological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : Covid+ or covid-
day of delivery
Immunological profile of newborns.
Time Frame: day of delivery
Describe the immunological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : IgG and/or IgM or absence
day of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 17, 2020

Primary Completion (ACTUAL)

May 19, 2020

Study Completion (ACTUAL)

August 2, 2021

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (ACTUAL)

May 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020/500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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