RecruitingNot Applicable

Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths

France200 participantsStarted 2020-10-05

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency difference of the determinant between the cases and the controls

Timeframe: 34 years

Trial details

NCT IDNCT04207814

SponsorUniversity Hospital, Brest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2057-10-05

Contact for this trial

Elisabeth Pasquier, MD

0298145013 elisabeth.pasquier@chu-brest.fr

View on ClinicalTrials.gov More Repeated Spontaneous Miscarriages trials