NCT04387253

Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID

Completed NA Last updated 12 July 2022

What this trial tests

NA trial testing Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus in Identification of the Mother or Fetus Contamination by SARS Cov-2 in 28 participants. Completed in 17 June 2022.

Timeline

23 May 2020

Primary endpoint
17 June 2022

17 June 2022

Quick facts

Lead sponsor	Poitiers University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	single
Primary purpose	diagnostic
Enrollment	28
Start date	23 May 2020
Primary completion	17 June 2022
Estimated completion	17 June 2022
Sites	1 location across France

Drugs / interventions tested

• Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus

Conditions studied

• Identification of the Mother or Fetus Contamination by SARS Cov-2 — all drugs for Identification of the Mother or Fetus Contamination by SARS Cov-2 →
• Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father — all drugs for Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father →
• The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes — all drugs for The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes →
• Analysis Laboratories of the Poitiers CHU — all drugs for Analysis Laboratories of the Poitiers CHU →

Sponsor

Poitiers University Hospital

Who can join

Eligibility, any sex, with Identification of the Mother or Fetus Contamination by SARS Cov-2 or Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses.

Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies.

If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination.

The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.