Labor Induction in Preeclampsia High-risk Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre-Eclampsia, Induction of Labor

Intervention / Treatment
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* Procedure: Induction of Labor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, biomarker, prediction, uterine artery pulsatility index, induction of labor, blood pressure, hypertension, mean arterial pressure, placental growth factor, pre-eclampsia