Impact of a Single Second-trimester Plasma sFlt-1 and/or Urinary PlGF Assay on Maternofetal Morbidity/Mortality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,040
- 试验地点
- 2
- 主要终点
- Reduction in the maternal and fetal morbimortality score
研究概览
简要总结
The purpose of this study is to determine whether close monitoring of patients with a high sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/ early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality and morbidity and 2/ a simple urinary PlGF screening will be effective.
详细描述
We will measure plasmatic sFlt-1 level between 25 and 28 weeks of gestation and flow velocity of uterine arteries by Doppler (22 - 26 weeks of gestation) in primipara. Patients will be stratified according to the results of the uterine artery Doppler measurement, and then randomized in two groups A and B. In group A, sFlt-1 concentration will be communicated to the obstetrician (+ or -): the threshold of abnormally high plasmatic concentration of sFlt-1 is 957 ng/mL. In patients with a high plasmatic concentration of sFlt-1 (+), the pregnancy will be closely monitored including repeated clinical, biological, and ultrasound examinations. Patients with sFlt-1 plasmatic concentration below 957 ng/mL (-) will be routinely followed-up.In group B, the result of sFlt-1 measurement will not be communicated and the pregnancy will be routinely monitored.Abnormal Doppler recordings in either group will result in a close monitoring as per our usual local practice. Urinary PlGF (expressed as a ratio PlGF/creatininemia) will also be measured and the results will be analyzed at the end of the study. Beside sFlt-1, we will store the plasmatic samples to measure other biomarkers that could be relevant in the future (no DNA analysis will be done without a new patient consent).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Pregnant womenAge ≥ 18 years
- •Followed in our center before the 28th week of gestation
- •Under social security coverage
- •Signed informed consent
排除标准
- •Age < 18 years
- •Followed in our center after the 28th week of gestation
- •No social security coverage
- •Refusal to be included
结局指标
主要结局
Reduction in the maternal and fetal morbimortality score
时间窗: During the pregnancy and the 3 first month of the child
次要结局
- Child status(at 3 months post-delivery)
- Length of hospital stay during pregnancy and post-partum periods(during pregnancy and post-partum periods)
- Predictive value for vascula-renal disease of urinary PlGF as compared with plasmatic sFlt-1.(between 25 and 28 weeks of gestation)