Labor Induction in Preeclampsia High-risk Women

Chinese University of Hong Kong825 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

825

Conditions

Pre-Eclampsia Induction of Labor

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (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WITHDRAWN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

Outcomes

Primary Outcomes

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.

Time frame: At Delivery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 28 days after birth

Labor Induction in Preeclampsia High-risk Women

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts