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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01690858
First received: November 29, 2011
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Fetal Losses
Other: blood sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • mutations in genes coding for molecules that modulate complement activity [ Time Frame: day1 (at inclusion) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • serum levels of sFlt1 and endoglin and their link to complement activation markers [ Time Frame: 4 weeks post pregnancy start ] [ Designated as safety issue: No ]
    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.

  • serum levels of sFlt1 and endoglin and their link to complement activation [ Time Frame: 8 weeks post pregnancy start ] [ Designated as safety issue: No ]
    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.

  • serum levels of sFlt1 and endoglin and their link to complement activation [ Time Frame: 16 weeks post pregnancy start ] [ Designated as safety issue: No ]
    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.

  • serum levels of sFlt1 and endoglin and their link to complement activation [ Time Frame: 24 weeks post pregnancy start ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

blood samples


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
females with medical history of repeated foetal losses
The females can be pregnant
Other: blood sample
blood sampling at inclusion and throughout pregnancy when pregnant
females without medical history of repeated foetal losses
The females can be pregnant
Other: blood sample
blood sampling at inclusion and throughout pregnancy when pregnant

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690858

Contacts
Contact: Fadi Fakhouri, Professsor +33 2 40 08 74 10 fadi.fakhouri@chu-nantes.fr

Locations
France
Antoine Beclere Hospital (AP-HP) Recruiting
Clamart, France, 92141
Contact: Alexandra BENACHI, PH    +33 145374476    alexandra.benachi@abc.aphp.fr   
Principal Investigator: Alexandra BENACHI, PH         
Sub-Investigator: Vanessa GALLOT, PH         
Sub-Investigator: Sophie NEDELLEC, PH         
CHU Recruiting
Nantes, France, 44093
Contact: Fadi Fakhouri, Professor         
Principal Investigator: Fadi Fakhouri, Professor         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01690858     History of Changes
Other Study ID Numbers: 10/6-K
Study First Received: November 29, 2011
Last Updated: December 7, 2012
Health Authority: France : French Health Products Safety Agency

Keywords provided by Nantes University Hospital:
Foetal loss
complement
antiangiogenic factors
Repeated fetal losses

Additional relevant MeSH terms:
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014