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

Not Applicable

Completed

• Conditions: The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes; Analysis Laboratories of the Poitiers CHU; 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

• Registration Number: NCT04387253
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-05-23
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-17
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Major patient
• Patient with late spontaneous abortion (≥15 weeks of gestation)
• Benefiting from a Social Security scheme
• Patient who consented to participate in the study
• Free subject, without tutorship, curatorship or subordination

Exclusion Criteria

• Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
• Concurrent participation in another clinical research study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause.	2 months	Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France