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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01690858
Enrollment
60
Registered
2012-09-24
Start date
2011-05-31
Completion date
2013-05-31
Last updated
2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Losses

Keywords

Foetal loss, complement, antiangiogenic factors, Repeated fetal losses

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.

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

Interventions

OTHERblood sample

blood sampling at inclusion and throughout pregnancy when pregnant

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
mutations in genes coding for molecules that modulate complement activityday1 (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

MeasureTime frameDescription
serum levels of sFlt1 and endoglin and their link to complement activation markers4 weeks post pregnancy startTo 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 activation8 weeks post pregnancy startTo 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026