CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42,454 enrolled
Drug / intervention
Low-dose aspirin in women with high risk of preeclampsiaother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03941886
NCT03941886N/ACompleted

Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia

Chiu Yee Liona Poon·interventional·Posted May 8, 2019·Updated Nov 29, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-Eclampsia
CountriesChina, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 8, 2019
Enrollment StartJul 31, 2019
Primary CompletionJun 15, 2023
Study CompletionAug 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.1 years ago

Interventions

Low-dose aspirin in women with high risk of preeclampsiaother

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