Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05056467
Status:
UNKNOWN
Last Update Posted:
2023-05-19
First Post:
2021-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Labor Induction in Preeclampsia High-risk Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007751', 'term': 'Labor, Induced'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 825}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of adverse placental outcomes', 'timeFrame': 'At Delivery', '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.'}], 'secondaryOutcomes': [{'measure': 'the rate of adverse maternal outcomes', 'timeFrame': '6 weeks Postpartum', '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.'}, {'measure': 'the rate of adverse neonatal outcomes', 'timeFrame': '28 days after birth', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aspirin', 'biomarker', 'blood pressure', 'hypertension', 'mean arterial pressure', 'placental growth factor', 'pre-eclampsia', 'prediction', 'uterine artery pulsatility index', 'induction of labor'], 'conditions': ['Pre-Eclampsia', 'Induction of Labor']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age no less than 18 years\n* Singleton pregnancy with cephalic presentation and no contraindication to vaginal delivery\n* Live fetus\n* Screened high-risk for PE\n* Informed and written consent\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Pregnant women who plan to have Cesarean delivery\n* Pregnancies complicated by the major fetal abnormality\n* Women who are severely ill, those with learning difficulties, or serious mental illness\n* Pregnant women with medical, obstetric, or fetal complications or any other indications for delivery before 39 weeks' gestation"}, 'identificationModule': {'nctId': 'NCT05056467', 'acronym': 'FORECAST-IOL', 'briefTitle': 'Labor Induction in Preeclampsia High-risk Women', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia', 'orgStudyIdInfo': {'id': '2021.249'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IOL', 'description': 'Preeclampsia High-risk Women schedule labor induction at 39 weeks of gestation', 'interventionNames': ['Procedure: Induction of Labor']}, {'type': 'NO_INTERVENTION', 'label': 'Expectant Management', 'description': 'Preeclampsia High-risk Women under expectant management'}], 'interventions': [{'name': 'Induction of Labor', 'type': 'PROCEDURE', 'description': 'Induction of Labor at 39 weeks of gestation', 'armGroupLabels': ['IOL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'status': 'WITHDRAWN', 'country': 'China', 'facility': "Angel Women's and Children's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Nanjing', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Liona CY Poon, MD', 'role': 'CONTACT', 'email': 'liona.poon@cuhk.edu.hk', 'phone': '(852) 3505 1290'}, {'name': 'So Ling Lau, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Aditya Kusuma', 'role': 'CONTACT'}], 'facility': 'Harapan Kita Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'city': 'Singapore', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tung-Yao Chang, MD', 'role': 'CONTACT'}], 'facility': 'Taiji Clinic', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Tuangsit Wataganara, MD', 'role': 'CONTACT'}], 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Hanoi', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Linh Dinh, MD', 'role': 'CONTACT'}], 'facility': 'Hanoi Obstetrics & Gynecology Hospital', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'centralContacts': [{'name': 'Liona POON, MD', 'role': 'CONTACT', 'email': 'liona.poon@cuhk.edu.hk', 'phone': '35051290'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanoi Obstetrics and Gynecology Hospital', 'class': 'OTHER'}, {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, {'name': 'Angel Women and Children Hospital', 'class': 'UNKNOWN'}, {'name': 'Rumah Sakit Anak dan Bunda Harapan Kita', 'class': 'UNKNOWN'}, {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, {'name': 'Taiji Clinic, Taiwan', 'class': 'UNKNOWN'}, {'name': 'Siriraj Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (Clinical)', 'investigatorFullName': 'Chiu Yee Liona Poon', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}