NCT05056467

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
825

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
7 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

September 20, 2021

Last Update Submit

May 18, 2023

Conditions

Pre-EclampsiaInduction of Labor

Keywords

aspirinbiomarkerblood pressurehypertensionmean arterial pressureplacental growth factorpre-eclampsiapredictionuterine artery pulsatility indexinduction of labor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the rate of adverse maternal outcomes

    6 weeks Postpartum

  • the rate of adverse neonatal outcomes

    28 days after birth

Study Arms (2)

IOL

EXPERIMENTAL

Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation

Procedure: Induction of Labor

Expectant Management

NO INTERVENTION

Preeclampsia High-risk Women under expectant management

Interventions

Induction of LaborPROCEDURE

Induction of Labor at 39 weeks of gestation

IOL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Angel Women's and Children's Hospital

Chengdu, China

WITHDRAWN

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, China

ACTIVE NOT RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Harapan Kita Hospital

Jakarta, Indonesia

RECRUITING

National University Hospital

Singapore, Singapore

ACTIVE NOT RECRUITING

Taiji Clinic

Taipei, Taiwan

RECRUITING

Siriraj Hospital

Bangkok, Thailand

RECRUITING

Hanoi Obstetrics & Gynecology Hospital

Hanoi, Vietnam

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaHypertension

Interventions

Labor, Induced

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Liona POON, MD

CONTACT

35051290liona.poon@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Clinical)

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 24, 2021

Study Start

January 1, 2022

Primary Completion

August 30, 2024

Study Completion

December 31, 2024

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

ID(1)CN(2)TW(1)HK(1)SG(1)TH(1)VN(1)