Trials / Completed
CompletedNCT03941886
Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)
Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42,454 (actual)
- Sponsor
- Chiu Yee Liona Poon · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Low-dose aspirin in women with high risk of preeclampsia | 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 |
Timeline
- Start date
- 2019-07-31
- Primary completion
- 2023-06-15
- Completion
- 2023-08-15
- First posted
- 2019-05-08
- Last updated
- 2023-11-29
Locations
19 sites across 10 countries: China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam
Source: ClinicalTrials.gov record NCT03941886. Inclusion in this directory is not an endorsement.