NCT01914809Unknown不适用
Micro Array Analysis in Preeclampsia
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- predictive markers of preeclampsia
研究概览
简要总结
Preeclampsia is a frequent pathology. His etiology is doubtful.
Targets :
The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.
Design:
Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).
The study of the transcriptional history of peripheral blood cells of 2patients groups:
- A patient group with a preeclampsia before 34 SA
- A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.
Results and perspectives
- Obtain a transcriptionnal signature of preeclampsia
- To identify new mechanism of the disease
- Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A prééclampsie (blood pressure superior to 140 mmHg and to 90 mmHg) and at least a cross of protein in the strip and/or more of 300mg / 24h after 20 LIMITED COMPANIES and before 34 limited companies.
- •An informed consent signed by the patient will necessarily have to be obtained.
- •Woman having been taken care during the pregnancy or at the time of the childbirth(delivery) by one of the participating teams to the current project.
- •Caucasian Patient
- •Wait primigeste and nullipare
排除标准
- •Major Patient protected by the law.
- •Patient deprived of freedom for administrative or judicial reasons.
- •Patient not benefiting from a national insurance scheme.
- •Refusal of the patient to participate in the study.
- •Not Caucasian Patient
- •Multipare Wait
- •Multiple Pregnancy
- •Existence of foetal deformation explaining a delay of growth or a foetal death in utero.
- •Age 18 years and > 40 years.
- •Absence of written consent or impossibility to receive the written consent (language or understanding).
结局指标
主要结局
predictive markers of preeclampsia
时间窗: 36 months
blood samples
次要结局
- analysis of placental transcriptional profile.(36 months)
研究者
研究点 (2)
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