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New treatment option for Repeated Spontaneous Miscarriages
Official title Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths
ClinicalTrials.gov ID: NCT04207814
What this study is testing
What is biological sample?
biological sample is an investigational medicine, being studied as a potential treatment for repeated spontaneous miscarriages.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join 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...
- the man must be over 18 years old.
- each member of the couple must consent to the investigation.
- people benefiting from a social security scheme.
You likely can't join 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.
See the full eligibility 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.
- people benefiting from a social security scheme.
- 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
- people not benefiting from a social security scheme
- Refusal to participate
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.