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.
Full Title of Study: “Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: August 30, 2024
- Procedure: Induction of Labor
- Induction of Labor at 39 weeks of gestation
Arms, Groups and Cohorts
- Experimental: IOL
- Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation
- No Intervention: Expectant Management
- Preeclampsia High-risk Women under expectant management
Clinical Trial Outcome Measures
- the rate of adverse placental outcomes
- Time Frame: 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.
- the rate of adverse maternal outcomes
- Time Frame: 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
- Time Frame: 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Chinese University of Hong Kong
- Hanoi Obstetrics and Gynecology Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Chiu Yee Liona Poon, Professor (Clinical) – Chinese University of Hong Kong
- Overall Contact(s)
- Liona POON, MD, 35051290, firstname.lastname@example.org
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