Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths
Recruiting now · Not applicable
Conditions studied: Repeated Spontaneous Miscarriages, Fetal Deaths in Utero
In brief
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.
Key facts
- Study ID
- NCT04207814
- Run by
- University Hospital, Brest
- People needed
- 200
- Starts
- 2020-10-05
- Expected to finish
- 2057-10-05
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- BREST — Brest, France (enrolling)
Full record on ClinicalTrials.gov
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