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Labor Induction in Preeclampsia High-risk Women (FORECAST-IOL)

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Enrolling

Conditions

Pre-Eclampsia
Induction of Labor

Treatments

Procedure: Induction of Labor

Study type

Interventional

Funder types

Other

Identifiers

NCT05056467
2021.249

Details and patient eligibility

About

Preeclampsia (PE) is one of the leading causes of maternal and perinatal morbidity and mortality. This pregnancy-specific disorder poses to both pregnant women and their offspring an increased risk of immediate and long-term health problems. The study team is conducting a study entitled "FORECAST" (Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial) and established the infrastructure for the first-trimester "screen and prevent" program for preterm PE. However, there is no established evidence regarding the benefit of scheduled labor induction versus expectant management among women identified as high-risk for PE with uncomplicated pregnancy at term. The investigators postulate that induction of labor at 39 weeks' gestation may possibly be an effective intervention to reduce placental complications in women with uncomplicated pregnancy by 39 weeks at high-risk PE women.

Enrollment

825 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age no less than 18 years
  • Singleton pregnancy with cephalic presentation and no contraindication to vaginal delivery
  • Live fetus
  • Screened high-risk for PE
  • Informed and written consent

Exclusion criteria

  • Multiple pregnancy
  • Pregnant women who plan to have Cesarean delivery
  • Pregnancies complicated by the major fetal abnormality
  • Women who are severely ill, those with learning difficulties, or serious mental illness
  • Pregnant women with medical, obstetric, or fetal complications or any other indications for delivery before 39 weeks' gestation

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

825 participants in 2 patient groups

IOL
Experimental group
Description:
Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation
Treatment:
Procedure: Induction of Labor
Expectant Management
No Intervention group
Description:
Preeclampsia High-risk Women under expectant management

Trial contacts and locations

8

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Central trial contact

Liona POON, MD

Data sourced from clinicaltrials.gov

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