Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
- Conditions
- Fetal Losses
- Interventions
- Other: blood sample
- Registration Number
- NCT01690858
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
The aim of the study is to assess the role of complement dysregulation and its impact on antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.
- Detailed Description
Females with medical history of repeated foetal losses will have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.
Controls will be females without medical history of repeated foetal losses. They will also have blood sampling to perform analyses. If pregnant, blood sampling will be performed at different times throughout the pregnancy.
Blood analyses will focus on :
* mutations in genes coding for molecules that modulate complement activity
* serum levels of sFlt1 and endoglin and their link to complement activation
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Inclusion criteria for females with repeated fetal losses:
- Age> 18
- Female affiliated to French health insurance (Social Security),
- Informed consent form signed
- Patient with history of at least three foetal losses without any cause found (chromosomal abnormalities, uterine malformations, endocrine disorders, etc.)
Exclusion criteria for females with repeated fetal losses :
- Patient not fulfilling inclusion criteria
- Age > 40
- Female unable to understand benefits and risks of protocol
- Female with history of repeated foetal losses of infectious or endocrine origin.
Inclusion criteria for females without repeated fetal losses:
- Age> 18
- Female affiliated to the French health insurance (Social Security)
- Informed consent form signed
- Female without history of repeated foetal losses
Exclusion criteria for females without repeated fetal losses:
- Patient not fulfilling inclusion criteria
- Female with age above 40
- Female unable to understand benefits and risks of protocol
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description females with medical history of repeated foetal losses blood sample The females can be pregnant females without medical history of repeated foetal losses blood sample The females can be pregnant
- Primary Outcome Measures
Name Time Method mutations in genes coding for molecules that modulate complement activity day1 (at inclusion) to determine frequency of mutations of genes (membrane-cofactor protein (MCP), decay accelerating factor (DAF), ....) involved in complement activation : Profiles of these genes will be analysed in blood sample of females with medical history of repeated foetal losses and compared to those analysed in blood sample of females without medical history of repeated foetal losses.
- Secondary Outcome Measures
Name Time Method serum levels of sFlt1 and endoglin and their link to complement activation markers 4 weeks post pregnancy start To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
serum levels of sFlt1 and endoglin and their link to complement activation 24 weeks post pregnancy start To assess serum levels of sFlt1 and endoglin and their link to complement activation markers in blood samples removed throughout pregnancy of females with medical history of repeated foetal losses and throughout pregnancy of females without medical history of repeated foetal losses.
Trial Locations
- Locations (2)
Antoine Beclere Hospital (AP-HP)
🇫🇷Clamart, France
CHU
🇫🇷Nantes, France