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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Fetal Losses

Treatments: Other: blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT01690858

10/6-K

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

60 participants in 2 patient groups

females with medical history of repeated foetal losses

Description:

The females can be pregnant

Treatment:

Other: blood sample

females without medical history of repeated foetal losses

Description:

The females can be pregnant

Treatment:

Other: blood sample