Maternal-foetal Transmission of SARS-Cov-2 (TMF-COVID-19)

June 14, 2021 updated by: Centre Hospitalier Régional d'Orléans

Maternal-Foetal Transmission of COVID-19

One case of maternal-fetal transmission of SARS Cov-2 was published (1). Ig M and Ig G were found at two hours after birth of a new born from a mother COVID-19. Another study on few newborns COVID-19 reported that the SARS-Cov-2 was not transmitted in utero but only after birth.

Although there are few data on COVID-19 during pregnancy, according to our national data collections, it appears to be responsible for miscarriages and fetal deaths. There are also intrauterine growth restrictions and an increase of the rate of cesarean sections for maternal indications. Therefore, it is essential to know if there is a maternal viremia which infects the fetus because the consequences in terms of management would be completely different.

In fact, the potential intrauterine infection will lead to antenatal monitoring of these patients with an antenatal diagnosis and may be a treatment.

Therefore, it seems essential to explore the mode of transmission to the newborn since many newborns have COVID-19 infection The investigators will propose to all pregnant women SARS- Cov-2 positive to perform PCR SARS-Cov-2 tests and /or serology's (IgM and Ig G) on the amniotic fluid, the blood cord and the placenta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pregnant women SARS cov-2 positives during pregnancy or during labor tested by a RT-PCR SARS-Cov-2 on nasopharyngeal swabs and/or by serologies.

After informed consent the ivestigators will proceed during labor to:

  1. A vaginal swab of amniotic fluid during the rupture of the water pocket during labor.

  2. a blood sample from the umbilical cord after delivery of the newborn and clamping and sectioning of the cord. PCR Covid-19 and serologies (Ig M and Ig G) as well as investigating viral proteome and cytokines.

    These are additional samples in addition to the routine samples which have no impact and without risk for the mother the newborn since they are taken after delivery from the side of the placenta after clamping and sectioning of the cord.

  3. Samples of 2 fragments of placenta after delivery of the placenta for COVID-19 research, which usually goes to waste or to pathology depending on the clinical context or for infectious tests. In all cases, samples of 3 to 4 cm3 will be taken which will in no way interfere with current analyzes carried out on the placenta which weighs one third of the fetal weight on average. A viral search by COVID-19 PCR will be carried out on the placenta fragment and another part will be frozen for analysis by electron microscopy and study of the viral proteome, cytokines and immune mechanisms. Placenta samples will be frozen at -80 degrees.

Study Type

Observational

Enrollment (Actual)

50

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
      • Orléans, France
        • CHR Orléans

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 to 48 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women COVID-19 positive or with suspected infection or presented a positive SARS Cov-2 PCR or serologies at any moment of the pregnancy. Symptomatic and asymptomatic pregnant women with SARS-Cov-2 will be included.

Description

Inclusion Criteria:

  • All pregnant women SARS-Cov-2 positive during the pregnancy
  • Informed consent obtained
  • 18 years to 48 years

Exclusion Criteria:

  • Pregnant women without SARS-Cov-2 infection ( PCR test and or serologies negatives)
  • curatorship patients.
  • Refusal to participate to the study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women COVID-19 positive by RT-PCR
Pregnant women COVID-19 positive by RT-PCR on nasopharyngeal swabs and/or by serology or with previous history of SARS-Cov-2 positive during the pregnancy coming to the maternity to deliver
Diagnostic test: Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta

During labor and delivery

  1. Sample of amniotic fluid
  2. 2 samples of blood cord after the birth of the new born
  3. 2 samples of placenta

These samples will be tested with A RT-PCR COVID-19 test and / or serology's A sample of blood cord and placenta will be frozen at -80 degree C and studied for PCR and viral proteome, cytokines , D-dimers and others inflammatory markers in the PRIMMO Laboratory (Prof. TOUMI and LESPESSAILLES) and after in the Centre of molecular biophysics of CNRS of Orleans (Prof. PICHON)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 by positive PCR in cord blood and / or positive serologies
Time Frame: Day 0
COVID-19 by positive PCR in cord blood and / or positive serologies
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 by positive PCR in amniotic fluid and placenta
Time Frame: Day 0
COVID-19 by positive PCR in amniotic fluid and placenta
Day 0
New born infected by COVID-19
Time Frame: Day 0
Newborn baby infected with COVID-19 on gastric tubing, rectal sample, nasopharyngeal samples by COVID-19 PCR and blood samples by serology
Day 0

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Régional d'Orléans

Collaborators

Centre de Biophysique Moléculaire - Pr Chantal Pichon
Professeur TOUMI Hechmi

Investigators

  • Principal Investigator: Souhail ALOUINI, M.D., Ph.D., CHR Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 5, 2020

Primary Completion (ACTUAL)

May 4, 2021

Study Completion (ACTUAL)

May 4, 2021

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (ACTUAL)

May 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 14, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2020-10

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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