Clinical trial NCT01690858: Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
Official title: Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Losses
Keywords: Foetal loss
complement
antiangiogenic factors
Repeated fetal losses
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with medical history of repeated foetal losses and females without medical history of repeated foetal losses as controls.

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

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: mutations in genes coding for molecules that modulate complement activity
timeFrame: day1 (at inclusion)
Secondary outcomes:
measure: serum levels of sFlt1 and endoglin and their link to complement activation markers
timeFrame: 4 weeks post pregnancy start
measure: serum levels of sFlt1 and endoglin and their link to complement activation
timeFrame: 8 weeks post pregnancy start
measure: serum levels of sFlt1 and endoglin and their link to complement activation
timeFrame: 16 weeks post pregnancy start
measure: serum levels of sFlt1 and endoglin and their link to complement activation
timeFrame: 24 weeks post pregnancy start
Other outcomes:
Locations:
city: Clamart
country: France
facility: Antoine Beclere Hospital (AP-HP)
city: Nantes
country: France
facility: CHU
Study officials:
References: