NCT01261351已完成不适用
Coagulation Activation Markers and Pre Eclampsia : Correlation With Complications
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Endogenous thrombin potential
研究概览
简要总结
The primary purpose of the trial is to evaluate coagulation activator markers in patients with pre eclampsia compared to control (normal pregnancy) and to correlate these markers with the severity of the pathology.
详细描述
100 pre-eclamptic patients will be compared to 200 control patients (100 control matched on gestational age at inclusion and 100 control matched on delivery mode (section).
Blood and urine samples will be collected at PE diagnosis, delivery and post partum.
Two axes will be considered:
- Thrombography, or kinetic measurement of thrombin generation, by studying the coagulant profile according to Hemker's method in CAT System (Calibrated Automated Thrombogram) and by thromboelastogram in ROTEM technique (delocalized coagulation analyzer), in parallel to specific activation markers (thrombin-antithrombin complex, fibrin monomers).
- The balance of prostacyclin/thromboxane A2 by using ELISA method for urine samples and genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase's promoter CYP8A1).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old
- •diagnosis of pre eclampsia
排除标准
- •multiple pregnancy
- •less than 18 year old
结局指标
主要结局
Endogenous thrombin potential
时间窗: at preeclampsia diagnosis
comparison of Endogenous thrombin potential between patients with Preclampsia (PE) (at the moment of the diagnosis of PE) compared to control (at the same gestational age)
次要结局
- In preeclampsia group : correlation between biological markers and severity of the disease(at the diagnosis of preeclampsia)
- evolution of endogenous thrombin potential in women with preeclampsia(between the diagnosis of preeclampsia and day 2 of the post partum period)
- genotype-phenotype correlation (Polymorphism of prostacyclin-synthetase promoter CYP8A1(at pre eclampsia diagnosis)
研究者
研究点 (1)
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