Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- mutations in genes coding for molecules that modulate complement activity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for females with repeated fetal losses:
- •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:
- •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
排除标准
- 未提供
结局指标
主要结局
mutations in genes coding for molecules that modulate complement activity
时间窗: 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.
次要结局
- 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(24 weeks post pregnancy start)