Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT01317706
Status:
COMPLETED
Last Update Posted:
2011-03-17
First Post:
2011-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Ultrasonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-16', 'studyFirstSubmitDate': '2011-03-16', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful labor induction', 'timeFrame': 'Eleven hours of initiating oxytocin on the fist day of induction', 'description': 'Induction success was defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of ≥ 4 cm within 11 hours of initiating oxytocin (i.e., within 22 hours of the administration of a dinoprostone vaginal insert) on the first day of induction.'}], 'secondaryOutcomes': [{'measure': 'the need for oxytocin induction', 'timeFrame': 'After removing prostaglandin, the following day when an intravenous oxytocin infusion was started', 'description': '1. the interval from start of oxytocin to the active phase of labor\n2. the interval from start of oxytocin to delivery\n3. vaginal delivery within 24 hours of starting induction\n4. the incidence of cesarean delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bishop score, Cervical length, Cervical ripening, Labor induction'], 'conditions': ['Failed Induction of Labor']}, 'descriptionModule': {'briefSummary': 'To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in nulliparas at term.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nulliparous patients\n* singleton pregnancy\n* live fetus with vertex presentation\n* intact amniotic membranes\n* \\> 37 weeks gestation\n* absence of labor\n* no previous uterine surgical procedures\n\nExclusion Criteria:\n\n* major congenital anomaly'}, 'identificationModule': {'nctId': 'NCT01317706', 'briefTitle': 'Comparison Between Ultrasonographic Cervical Length and Bishop Score in Preinduction Cervical Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'BS_CL_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bishop score', 'interventionNames': ['Other: Assessment of cervical status']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transvaginal ultrasound', 'interventionNames': ['Other: Assessment of cervical status']}], 'interventions': [{'name': 'Assessment of cervical status', 'type': 'OTHER', 'description': 'Assessment of cervical status based on Bishop score versus sonographically measured cervical length', 'armGroupLabels': ['Bishop score', 'transvaginal ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Department of Obstetrics and Gynecology Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Kyo Hoon Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seoul National University Bundang Hospital', 'oldOrganization': 'Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital'}}}}