Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths

NCT04207814 | Recruiting

• 1 other identifier: DEFI-2 (29BRC19.0241)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The DEFI-1 study recruited 625 women witnesses and 299 of their spouses. With regard to case couples, 271 cases were recruited from the spontaneous repeated miscarriages (SRM) subgroup (≥3 spontaneous miscarriage (SM) from trimester 1 of pregnancy) and 93 from the unexplained fetal death in utero (FDIU) subgroup from trimesters 2 and 3 of pregnancy. The main objective of the DEFI 2 study is to increase the number of case-pairs in these 2 particular subgroups to replicate the results of the genetic determinants highlighted from cases and controls with extreme phenotypes and obtain a sufficient number of women with FDIUs to identify specific determinants.

Conditions

Repeated Spontaneous Miscarriages; Fetal Deaths in Utero

Outcome Measures

Primary Outcomes (1)

• Frequency difference of the determinant between the cases and the controls

  The frequency difference of the determinant under study between the cases (studies DEFI-1 and DEFI-2) and the controls (study DEFI-1) will be measured.

  34 years

Secondary Outcomes (1)

• Occurrence of a new medical event

  34 years

Study Arms (1)

Cases

EXPERIMENTAL

Biological: biological sample

Interventions

biological sample BIOLOGICAL

biological samples will be taken from the subjects included

Cases

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• couples whose wife is over 18 and under 40 inclusive,
• couples having undergone at least 3 unexplained SM in the first trimester or an FDIU in the trimesters 2 and 3 of pregnancy (excluding funicular and fetal causes and proven preeclampsia)
• the man must be over 18 years old.
• each member of the couple must consent to the investigation.
• Subjects benefiting from a social security scheme.

You may not qualify if:

• couples where the woman is under 18 or over 40,
• couples whose man is under 18,
• identified cause of SRM or FDIU
• Inability to consent for one of the members of the couple,
• refusal to participate for one of the members of the couple.
• treatment with anticoagulants or anti-aggregating platelet for women.
• Person under legal protection
• Subjects not benefiting from a social security scheme
• Refusal to participate

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

BREST

Brest, 29200, France

RECRUITING

Study Officials

• Elisabeth Pasquier, MD

  Brest University Hospital in France

  STUDY DIRECTOR

Central Study Contacts

Elisabeth Pasquier, MD

CONTACT

0298145013; elisabeth.pasquier@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case couples

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: October 5, 2020
• Primary Completion (Estimated): October 5, 2057
• Study Completion (Estimated): October 5, 2057
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)