Labor Induction in Preeclampsia High-risk Women

Not Applicable

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IOL	Induction of Labor	Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation

Primary Outcome Measures

Name	Time	Method
the rate of adverse placental outcomes	At Delivery	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.

Secondary Outcome Measures

Name	Time	Method
the rate of adverse maternal outcomes	6 weeks Postpartum	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.
the rate of adverse neonatal outcomes	28 days after birth	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.

Locations (8): Angel Women's and Children's Hospital
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Chengdu, China
Harapan Kita Hospital
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Jakarta, Indonesia
Prince of Wales Hospital
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Hong Kong, Hong Kong
National University Hospital
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Singapore, Singapore
Taiji Clinic
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Taipei, Taiwan
Siriraj Hospital
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Bangkok, Thailand
Hanoi Obstetrics & Gynecology Hospital
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Hanoi, Vietnam
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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Nanjing, China