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

NCT ID: NCT04387253

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-23
• Study Completion Date: 2022-06-17

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Interventions

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

Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Presence of SARS-COV-2 virus in samples taken from mother and father. Circulating anti-SARS-COV-2 antibodies in the mother.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

GYNE-COVID

Identifier Type: -

Identifier Source: org_study_id