Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions

Nantes University Hospital60 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Fetal Losses

Interventions

blood sampleOTHER

blood sampling at inclusion and throughout pregnancy when pregnant

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

CHU

Nantes, France, France

Antoine Beclere Hospital (AP-HP)

Clamart, France

Outcomes

Primary Outcomes

mutations in genes coding for molecules that modulate complement activity

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.

Time frame: day1 (at inclusion)

Secondary Outcomes

serum levels of sFlt1 and endoglin and their link to complement activation markers

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.

Time frame: 4 weeks post pregnancy start

serum levels of sFlt1 and endoglin and their link to complement activation

Time frame: 8 weeks post pregnancy start

serum levels of sFlt1 and endoglin and their link to complement activation

Time frame: 16 weeks post pregnancy start

serum levels of sFlt1 and endoglin and their link to complement activation

Data from ClinicalTrials.gov

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