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Maternal-foetal Transmission of SARS-Cov-2

Maternal-Foetal Transmission of COVID-19

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04395924
Acronym
TMF-COVID-19
Enrollment
50
Registered
2020-05-20
Start date
2020-05-05
Completion date
2021-05-04
Last updated
2021-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pregnancy, RT-PCR-COVID-19, SARS-CoV 2 serologies, Placenta, Blood cord, Amniotic fluid

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTDiagnosis 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

Centre de Biophysique Moléculaire - Pr Chantal Pichon
CollaboratorUNKNOWN
Professeur TOUMI Hechmi
CollaboratorUNKNOWN
Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
COVID-19 by positive PCR in cord blood and / or positive serologiesDay 0COVID-19 by positive PCR in cord blood and / or positive serologies

Secondary

MeasureTime frameDescription
COVID-19 by positive PCR in amniotic fluid and placentaDay 0COVID-19 by positive PCR in amniotic fluid and placenta
New born infected by COVID-19Day 0Newborn baby infected with COVID-19 on gastric tubing, rectal sample, nasopharyngeal samples by COVID-19 PCR and blood samples by serology

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026