Labor Induction in Preeclampsia High-risk Women

Pre-Eclampsia Clinical Trial

— FORECAST-IOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056467
• Other study ID #: 2021.249
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Chinese University of Hong Kong
• Contact: Liona POON, MD
• Phone: 35051290
• Email: liona.poon[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 825
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Eclampsia
• Induction of Labor
• Pre-Eclampsia

Intervention

Procedure:
• Induction of Labor
Induction of Labor at 39 weeks of gestation

Locations

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

Sponsors (8)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Angel Women and Children Hospital, Hanoi Obstetrics and Gynecology Hospital, National University Hospital, Singapore, Rumah Sakit Anak dan Bunda Harapan Kita, Siriraj Hospital, Taiji Clinic, Taiwan, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Countries where clinical trial is conducted

China,  Hong Kong,  Indonesia,  Singapore,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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