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

Analysis Laboratories of the Poitiers CHU Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387253
• Other study ID #: GYNE-COVID
• Status: Completed
• Phase: N/A
• Start date: May 23, 2020
• Est. completion date: June 17, 2022

Study information

• Verified date: July 2022
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• 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
• The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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