Investigating Causes of Repeated Miscarriages and Fetal Deaths
Official title: Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths (DEFI-2)
Run by University Hospital, Brest · NCT04207814 · Data updated 2026-11-12
This study is trying to find out the genetic and biological reasons behind repeated miscarriages and fetal deaths by looking at couples who have experienced these issues.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Status | Recruiting |
| Started | October 5, 2020 |
| Main results expected | October 5, 2057 |
| Study ends | October 5, 2057 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT04207814 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are couples where the woman is aged 18-40 and has experienced at least three unexplained miscarriages or a fetal death in the second or third trimester.
✕Probably not a fit
Patients with identified causes of their miscarriages or fetal deaths, or those outside the specified age range, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The DEFI-2 study aims to recruit additional couples affected by repeated spontaneous miscarriages and unexplained fetal deaths to better understand the genetic and biological factors involved. It builds on previous findings from the DEFI-1 study, which explored various potential causes of these conditions, including prothrombotic processes and immunological disorders. By increasing the number of case-pairs, the study seeks to replicate and validate earlier results and identify specific determinants that may contribute to these pregnancy complications. Participants will provide biological samples to facilitate this research.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and potential treatments for couples experiencing repeated miscarriages and fetal deaths.
How similar studies have gone: Previous studies have indicated potential genetic and biological factors in similar conditions, but this specific approach is novel in its focus on expanding the case-pair analysis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where it's running
-
Brest
Brest, France Recruiting
Study contacts
- Study coordinator: Elisabeth Pasquier, MD
- Email: elisabeth.pasquier@chu-brest.fr
- Phone: 0298145013
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.