Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42,454
- 试验地点
- 20
- 主要终点
- Delivery with preterm-preeclampsia
研究概览
简要总结
This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy;
- •Live fetus;
排除标准
- •Multiple pregnancy;
- •Major fetal defects identified at 11-13 weeks of assessment;
- •Non-viable fetus (missed spontaneous abortion or stillbirth).
结局指标
主要结局
Delivery with preterm-preeclampsia
时间窗: Before 37 weeks of gestation
Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups
次要结局
- Low birth weight(at birth)
- Spontaneous preterm birth(At <34 and <37 weeks' gestation)
- Adverse outcomes with delivery at <34, <37 and ≥37 weeks of gestation(at <34, <37 and ≥37 weeks of gestation)
- Gestational age at delivery(at delivery)
- Composite neonatal therapy(during the first 28 days of life (0-27 days))
- Neonatal mortality(during the first 28 days of life (0-27 days))
- Stillbirth(at or after 20 to 28 weeks of pregnancy)
- Acceptability for PE screening(in the first trimester of pregnancy (11-13 weeks of gestation))
- Acceptability for aspirin treatment.(from <15 weeks till 36 weeks of gestation or, in the event of early delivery, at the onset of labor)
- Composite neonatal morbidity(during the first 28 days of life (0-27 days))
研究者
Chiu Yee Liona Poon
Professor (Clinical)
Chinese University of Hong Kong