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

Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia; Induction of Labor
• Intervention / Treatment: Procedure: Induction of Labor

• Study Type: Interventional
• Enrollment (Anticipated): 825
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liona POON, MD; Phone Number: 35051290; Email: liona.poon@cuhk.edu.hk

Study Locations

• China
  • Chengdu, China
    • Withdrawn
    • Angel Women's and Children's Hospital
  • Nanjing, China
    • Active, not recruiting
    • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Liona CY Poon, MD; Phone Number: (852) 3505 1290; Email: liona.poon@cuhk.edu.hk
    • Principal Investigator: So Ling Lau, MBChB
• Indonesia
  • Jakarta, Indonesia
    • Recruiting
    • Harapan Kita Hospital
    • Contact: Aditya Kusuma
• Singapore
  • Singapore, Singapore
    • Active, not recruiting
    • National University Hospital
• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taiji Clinic
    • Contact: Tung-Yao Chang, MD
• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Siriraj Hospital
    • Contact: Tuangsit Wataganara, MD
• Vietnam
  • Hanoi, Vietnam
    • Recruiting
    • Hanoi Obstetrics & Gynecology Hospital
    • Contact: Linh Dinh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IOL; Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation	Procedure: Induction of Labor; Induction of Labor at 39 weeks of gestation
No Intervention: Expectant Management; Preeclampsia High-risk Women under expectant management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of adverse placental outcomes	To compare the difference in the rate of adverse placental outcomes (PE, gestational hypertension (GH), SGA, stillbirth, perinatal death, placental abruption) in the induction of labor group with the expectant management group.	At Delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of adverse maternal outcomes	To compare the difference in the rate of maternal secondary outcomes including composite outcomes of the following: Cesarean delivery/indication for Cesarean delivery, operative vaginal delivery, indication for operative vaginal delivery, uterine incisional extensions during Cesarean delivery, chorioamnionitis, third-degree or fourth-degree perineal laceration, postpartum hemorrhage, postpartum infection, venous thromboembolism, number of hours in the labor and delivery unit, length of postpartum hospital stay, admission to the intensive care unit, and maternal death, between the induction of labor group and the expectant management group.	6 weeks Postpartum
the rate of adverse neonatal outcomes	To compare the difference in the rate of neonatal secondary outcomes including the composite outcomes of the following: perinatal death or severe neonatal complications and consisted of one or more of the following during the antepartum or intrapartum period or during the delivery hospitalization between the induction of labor group and the expectant management group.	28 days after birth

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: National University Hospital, Singapore; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Siriraj Hospital; Hanoi Obstetrics and Gynecology Hospital; Angel Women and Children Hospital; Rumah Sakit Anak dan Bunda Harapan Kita; Taiji Clinic, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: biomarker; hypertension; blood pressure; aspirin; prediction; pre-eclampsia; induction of labor; mean arterial pressure; placental growth factor; uterine artery pulsatility index
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 2021.249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No