Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths (DEFI-2)
Primary Purpose
Repeated Spontaneous Miscarriages, Fetal Deaths in Utero
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological sample
Sponsored by
About this trial
This is an interventional other trial for Repeated Spontaneous Miscarriages
Eligibility 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
Sites / Locations
- CHRU Brest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cases
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Occurrence of a new medical event
Occurrence of a new medical event in prospective follow-up will be evaluated
Full Information
NCT ID
NCT04207814
First Posted
December 19, 2019
Last Updated
December 19, 2019
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04207814
Brief Title
Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths
Acronym
DEFI-2
Official Title
Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths (DEFI-2)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2054 (Anticipated)
Study Completion Date
January 2054 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The spontaneous repeated miscarriages (SRM) affect one to two fertile couples on 100, a fetal death in utero (FDIU) complicates the evolution of a pregnancy on 200. The SRM remain unexplained in 50% of the cases although a beam indirect arguments sometimes encourage to evoke a prothrombotic process and / or endothelial dysfunction, immunological disorders, an alteration of the ovarian reserve, and possibly the impact of genetic determinants. Regarding SRM, in the absence of a fetal, funicular cause or obvious preeclampsia, very diverse mechanisms are evoked depending on the placental histology (vasculoplacental, inflammatory, intervillitis, immunological, etc.). Thus, while these mechanisms remain for some to be demonstrated and are probably not unequivocal, clinicians are faced with a pressing request for therapeutic intervention on the part of patients. This is why, after having studied in DEFI-1 the 2 main constitutional thrombophilia in the 2 members of the couple, the procoagulant circulating microparticles and the generation of thrombin in the mother on the one hand, the modalities of inactivation of an X in the mother, on the other hand, a further investigation in subgroups of particular cases would be appropriate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Repeated Spontaneous Miscarriages, Fetal Deaths in Utero
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case couples
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
biological sample
Intervention Description
biological samples will be taken from the subjects included
Primary Outcome Measure Information:
Title
Frequency difference of the determinant between the cases and the controls
Description
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.
Time Frame
34 years
Secondary Outcome Measure Information:
Title
Occurrence of a new medical event
Description
Occurrence of a new medical event in prospective follow-up will be evaluated
Time Frame
34 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Pasquier, MD
Phone
0298145013
Ext
+33
Email
elisabeth.pasquier@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Pasquier, MD
Organizational Affiliation
Brest University Hospital in France
Official's Role
Study Director
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Pasquier, MD
Phone
0298145013
Ext
+33
Email
elisabeth.pasquier@chu-brest.fr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing 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.
Learn more about this trial
Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths
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