Pre-EclampsiaFORECAST-IOLNCT05056467
Labor Induction in Preeclampsia High-risk Women
A study testing Induction of Labor in people with Pre-Eclampsia and Induction of Labor, run by Chinese University of Hong Kong at 8 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia, Induction of Labor
- What is being tested?
- Induction of Labor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
China2 sites
- Withdrawn
Angel Women's and Children's Hospital
Chengdu
- Active, not recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Liona CY Poon, MD, (852) 3505 1290, liona.poon@cuhk.edu.hk
So Ling Lau, MBChB
Indonesia1 site, 1 recruiting
- Recruiting
Harapan Kita Hospital
Jakarta
Aditya Kusuma
Singapore1 site
- Active, not recruiting
National University Hospital
Singapore
Thailand1 site, 1 recruiting
- Recruiting
Siriraj Hospital
Bangkok
Tuangsit Wataganara, MD
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Obstetrics & Gynecology Hospital
Hanoi
Linh Dinh, MD
About this study
Official title: Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia
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.
- Conditions
- Pre-Eclampsia, Induction of Labor
- Being tested
- 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
- Medical subject headings
- Pre-Eclampsia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of LaborProcedure or surgery
Induction of Labor at 39 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| IOL | Experimental | Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation Receives: Procedure: Induction of Labor |
| Expectant Management | No intervention | Preeclampsia High-risk Women under expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Delivery
Secondary outcomes (2)
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.
Measured: 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.
Measured: 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Jan 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Chiu Yee Liona Poon, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056467
- Sponsor's protocol ID
- 2021.249
- Acronym
- FORECAST-IOL
- Status last verified
- May 2023
- First submitted
- 20 Sep 2021
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia
- ClinicalTrials.gov ID
- NCT05056467
- Acronym / sponsor ID
- FORECAST-IOL / 2021.249
- Conditions
- Pre-Eclampsia, Induction of Labor
- Keywords
- aspirin, biomarker, blood pressure, hypertension, mean arterial pressure, placental growth factor, pre-eclampsia, prediction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- 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
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL | Experimental | Procedure: Induction of LaborPreeclampsia High-risk Women schedule labor induction at 39 weeks of gestation |
| Expectant Management | No intervention | –Preeclampsia High-risk Women under expectant management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of LaborInduction of Labor at 39 weeks of gestation | Procedure or surgery | IOL |
Primary outcome
the rate of adverse placental outcomes
Time frame: 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.
2 secondary outcomes
the rate of adverse maternal outcomes
Time frame: 6 weeks Postpartum
the rate of adverse neonatal outcomes
Time frame: 28 days after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction of Labor in people with Pre-Eclampsia and Induction of Labor, run by Chinese University of Hong Kong at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Hong Kong, Indonesia, Singapore, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liona POON, MD (35051290, liona.poon@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of adverse placental outcomes (time frame: At Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.