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

Chiu Yee Liona Poon

Status: Completed

Conditions: Pre-Eclampsia

Treatments: Other: Low-dose aspirin in women with high risk of preeclampsia

Study type: Interventional

Funder types: Other

Identifiers

NCT03941886

2018-0434

Details and patient eligibility

About

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.

Enrollment: 42,454 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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42,454 participants in 2 patient groups

Non-intervention group

No Intervention group

Description:

Participants receive routine prenatal care

Intervention group

Experimental group

Description:

Participants receive first-trimester screening for preterm-preeclampsia by the Bayes based method followed by commencement of low-dose aspirin prophylaxis in high-risk women.

Treatment:

Other: Low-dose aspirin in women with high risk of preeclampsia