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Completed

NCT Number: NCT04395924

Maternal-foetal Transmission of SARS-Cov-2

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.

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Key information

Conditions

Maternal Fetal Infection Transmission COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

CHR Orléans

Orléans, France

About this study

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:

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

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta

Diagnostic Test

During labor and delivery

  • Sample of amniotic fluid
  • 2 samples of blood cord after the birth of the new born
  • 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)

Primary outcomes

  1. 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

Secondary outcomes

  1. COVID-19 by positive PCR in amniotic fluid and placenta

    Time frame: Day 0

    COVID-19 by positive PCR in amniotic fluid and placenta

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Collaborators

  • Centre de Biophysique Moléculaire - Pr Chantal Pichon
  • Professeur TOUMI Hechmi

Registry information

Official study title

Maternal-Foetal Transmission of COVID-19

Acronym: TMF-COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 20, 2020
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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