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Completed

NCT Number: NCT01690858

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU, Nantes, France

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

blood sampling at inclusion and throughout pregnancy when pregnant

Primary outcomes

  1. mutations in genes coding for molecules that modulate complement activity

    Time frame: day1 (at inclusion)

    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 outcomes

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

    Time frame: 4 weeks post pregnancy start

    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.

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

    Time frame: 8 weeks post pregnancy start

    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.

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

    Time frame: 16 weeks post pregnancy start

    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.

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

    Time frame: 24 weeks post pregnancy start

    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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 24, 2012
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.