Completed

NCT Number: NCT04387253

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.

Completed

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Key information

Conditions

Identification of the Mother or Fetus Contamination by SARS Cov-2 Analysis Laboratories of the Poitiers CHU 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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause.

Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: May 13, 2020
Registry last updated: Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.