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Labor Induction in Preeclampsia High-risk Women (FORECAST-IOL)

Primary Purpose

Pre-Eclampsia, Induction of Labor

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Induction of Labor
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Eclampsia focused on measuring aspirin, biomarker, blood pressure, hypertension, mean arterial pressure, placental growth factor, pre-eclampsia, prediction, uterine artery pulsatility index, induction of labor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Angel Women's and Children's Hospital
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • Prince of Wales HospitalRecruiting
  • Harapan Kita HospitalRecruiting
  • National University Hospital
  • Taiji ClinicRecruiting
  • Siriraj HospitalRecruiting
  • Hanoi Obstetrics & Gynecology HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IOL

Expectant Management

Arm Description

Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation

Preeclampsia High-risk Women under expectant management

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 20, 2021
Last Updated
May 18, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05056467
Brief Title
Labor Induction in Preeclampsia High-risk Women
Acronym
FORECAST-IOL
Official Title
Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
825 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IOL
Arm Type
Experimental
Arm Description
Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation
Arm Title
Expectant Management
Arm Type
No Intervention
Arm Description
Preeclampsia High-risk Women under expectant management
Intervention Type
Procedure
Intervention Name(s)
Induction of Labor
Intervention Description
Induction of Labor at 39 weeks of gestation
Primary Outcome Measure Information:
Title
the rate of adverse placental outcomes
Description
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.
Time Frame
At Delivery
Secondary Outcome Measure Information:
Title
the rate of adverse maternal outcomes
Description
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.
Time Frame
6 weeks Postpartum
Title
the rate of adverse neonatal outcomes
Description
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.
Time Frame
28 days after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liona POON, MD
Phone
35051290
Email
liona.poon@cuhk.edu.hk
Facility Information:
Facility Name
Angel Women's and Children's Hospital
City
Chengdu
Country
China
Individual Site Status
Withdrawn
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liona CY Poon, MD
Phone
(852) 3505 1290
Email
liona.poon@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
So Ling Lau, MBChB
Facility Name
Harapan Kita Hospital
City
Jakarta
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aditya Kusuma
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Taiji Clinic
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tung-Yao Chang, MD
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuangsit Wataganara, MD
Facility Name
Hanoi Obstetrics & Gynecology Hospital
City
Hanoi
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linh Dinh, MD

12. IPD Sharing Statement

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Labor Induction in Preeclampsia High-risk Women

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