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Maternal-foetal Transmission of SARS-Cov-2

NCT04395924 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Maternal Fetal Infection Transmission
  • COVID-19
  • SARS-CoV 2

Interventions

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)

Sponsors & Collaborators

  • Centre de Biophysique Moléculaire - Pr Chantal Pichon

    collaborator UNKNOWN

  • Professeur TOUMI Hechmi

    collaborator UNKNOWN

  • Centre Hospitalier Régional d'Orléans

    lead OTHER

Principal Investigators

  • Souhail ALOUINI, M.D., Ph.D. · CHR ORLEANS

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2021-05-04
Completion
2021-05-04

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04395924 on ClinicalTrials.gov