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

NCT ID: NCT01690858

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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

Conditions

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Fetal Losses

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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females with medical history of repeated foetal losses

The females can be pregnant

blood sample

Intervention Type OTHER

blood sampling at inclusion and throughout pregnancy when pregnant

females without medical history of repeated foetal losses

The females can be pregnant

blood sample

Intervention Type OTHER

blood sampling at inclusion and throughout pregnancy when pregnant

Interventions

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blood sample

blood sampling at inclusion and throughout pregnancy when pregnant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.)

* Age \> 40
* Female unable to understand benefits and risks of protocol
* Female with history of repeated foetal losses of infectious or endocrine origin.


* Age\> 18
* Female affiliated to the French health insurance (Social Security)
* Informed consent form signed
* Female without history of repeated foetal losses

* Female with age above 40
* Female unable to understand benefits and risks of protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU

Nantes, France, France

Site Status

Antoine Beclere Hospital (AP-HP)

Clamart, , France

Site Status

Countries

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France

Other Identifiers

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10/6-K

Identifier Type: -

Identifier Source: org_study_id

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