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

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.

Study Overview

• Status: Completed
• Conditions: 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; The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes; Analysis Laboratories of the Poitiers CHU
• Intervention / Treatment: Diagnostic test: Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Chu de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2020
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: GYNE-COVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No