Induction of Labor, Pre-Eclampsia
Conditions
Keywords
aspirin, biomarker, blood pressure, hypertension, mean arterial pressure, placental growth factor, pre-eclampsia, prediction, uterine artery pulsatility index, induction of labor
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.
Interventions
PROCEDUREInduction of Labor
Induction of Labor at 39 weeks of gestation
Sponsors
Hanoi Obstetrics and Gynecology Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Angel Women and Children Hospital
Rumah Sakit Anak dan Bunda Harapan Kita
National University Hospital, Singapore
Taiji Clinic, Taiwan
Siriraj Hospital
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China, Hong Kong, Indonesia, Singapore, Taiwan, Thailand, Vietnam
Contacts
Primary ContactLiona POON, MD
Outcome results
None listed