Clinical trial NCT05056467: Labor Induction in Preeclampsia High-risk Women
Official title: Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Induction of Labor
Keywords: aspirin
biomarker
blood pressure
hypertension
mean arterial pressure
placental growth factor
pre-eclampsia
prediction
uterine artery pulsatility index
induction of labor
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hanoi Obstetrics and Gynecology Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Angel Women and Children Hospital
name: Rumah Sakit Anak dan Bunda Harapan Kita
name: National University Hospital, Singapore
name: Taiji Clinic, Taiwan
name: Siriraj Hospital
First posted: 2021-09-24
Enrollment: 825
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: the rate of adverse placental outcomes
timeFrame: At Delivery
Secondary outcomes:
measure: the rate of adverse maternal outcomes
timeFrame: 6 weeks Postpartum
measure: the rate of adverse neonatal outcomes
timeFrame: 28 days after birth
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Angel Women's and Children's Hospital
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Jakarta
country: Indonesia
facility: Harapan Kita Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Taipei
country: Taiwan
facility: Taiji Clinic
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Hanoi
country: Vietnam
facility: Hanoi Obstetrics & Gynecology Hospital
Study officials:
References: