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

NCT01690858 | Completed

• 1 other identifier: 10/6-K
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Fetal Losses

Keywords

Foetal loss; complement; antiangiogenic factors; Repeated fetal losses

Outcome Measures

Primary Outcomes (1)

• 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.

  day1 (at inclusion)

Secondary Outcomes (4)

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

  4 weeks post pregnancy start

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

  8 weeks post pregnancy start

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

  16 weeks post pregnancy start

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

  24 weeks post pregnancy start

Study Arms (2)

females with medical history of repeated foetal losses

The females can be pregnant

Other: blood sample

females without medical history of repeated foetal losses

The females can be pregnant

Other: blood sample

Interventions

blood sample OTHER

blood sampling at inclusion and throughout pregnancy when pregnant

females with medical history of repeated foetal losses; females without medical history of repeated foetal losses

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU

Nantes, France, 44093, France

Location

Antoine Beclere Hospital (AP-HP)

Clamart, 92141, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: September 24, 2012
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

FR (2)