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Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)

NCT03941886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42454

Last updated 2023-11-29

No results posted yet for this study

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

  • Pre-Eclampsia

Interventions

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

Sponsors & Collaborators

  • Chiu Yee Liona Poon

    lead OTHER

Principal Investigators

  • Liona CY Poon, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2023-06-15
Completion
2023-08-15

Countries

  • China
  • Hong Kong
  • Indonesia
  • Japan
  • Malaysia
  • Philippines
  • Singapore
  • Taiwan
  • Thailand
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941886 on ClinicalTrials.gov