Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pre-Eclampsia
- Sponsor
- Chiu Yee Liona Poon
- Enrollment
- 42454
- Locations
- 19
- Primary Endpoint
- Delivery with preterm-preeclampsia
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Chiu Yee Liona Poon
Professor (Clinical)
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Singleton pregnancy;
- •Live fetus;
Exclusion Criteria
- •Multiple pregnancy;
- •Major fetal defects identified at 11-13 weeks of assessment;
- •Non-viable fetus (missed spontaneous abortion or stillbirth).
Outcomes
Primary Outcomes
Delivery with preterm-preeclampsia
Time Frame: Before 37 weeks of gestation
Proportions of delivery with preterm preeclampsia between non-intervention and intervention groups
Secondary Outcomes
- 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))