At a glance
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Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
In Brief
A clinical study evaluating Low-dose aspirin in women with high risk of preeclampsia for Pre-Eclampsia. Completed, enrolled 42,454 participants across 19 sites in 10 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Low-dose aspirin 150-162 mg/night or 100 mg/night if body weight \<40 Kg, from \<15 weeks till 36 weeks or, in the event of early delivery, at the onset of labor