Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04220320
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2020-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Success of Labor Induction Based on a Modified BISHOP Score.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058869', 'term': 'Gynecological Examination'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 758}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2022-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to delivery', 'timeFrame': 'Up to 72 hours.', 'description': 'The time from induction commencement to delivery of the newborn.'}], 'secondaryOutcomes': [{'measure': 'BISHOP score after primary induction.', 'timeFrame': 'Up to 24 hours.', 'description': 'BISHOP score after primary induction. BISHOP is not an abbreviation and is just the name of the score. The minimum score is 0 and the maximum score is 13. The higher the score, the more favorable the cervix is considered before induction of labor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Induction of Labor Affected Fetus / Newborn']}, 'descriptionModule': {'briefSummary': 'Pregnant women at term will be divided randomly into 3 groups:\n\n1. Gynecological evaluation based on classic BISHOP score.\n2. Gynecological evaluation based on a modified BISHOP score.\n3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.\n\nAfter gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of.', 'detailedDescription': "Women presenting to the obstetric emergency room for follow-up for various obstetric/other medical conditions over 37 weeks' gestation that are candidates for labor induction will receive an explanation regarding the study and sign informed consent.\n\nThe women will be divided randomly into 3 groups:\n\n1. Gynecological evaluation based on classic BISHOP score.\n2. Gynecological evaluation based on a modified BISHOP score.\n3. Gynecological evaluation based on cervical length as measured by transvaginal sonography.\n\nAfter gynecological evaluation, women will undergo induction of labor based on obstetric evaluation according to the group they were part of."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pregnant women over 37 weeks' gestation that are candidates for induction of labor for obstetric/other medical indications.", 'genderDescription': 'Female.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancies.\n* Candidates for vaginal delivery.\n\nExclusion Criteria:\n\n* Multiple pregnancies.\n* Candidates for cesarean section.'}, 'identificationModule': {'nctId': 'NCT04220320', 'briefTitle': 'The Success of Labor Induction Based on a Modified BISHOP Score.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Success of Labor Induction Based on a Modified BISHOP Score Compared to Classic BISHOP Score and Cervical Length in Transvaginal Sonography.', 'orgStudyIdInfo': {'id': '0622-19-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Classic BISHOP score', 'description': 'Gynecological evaluation based on vaginal examination including cervical dilatation, effacement, texture, station and position.', 'interventionNames': ['Diagnostic Test: Vaginal examination.']}, {'label': 'Modified BISHOP score', 'description': 'Gynecological evaluation based on vaginal examination including cervical dilatation and effacement alone.', 'interventionNames': ['Diagnostic Test: Vaginal examination.']}, {'label': 'Cervical Length', 'description': 'Gynecological evaluation based on cervical length measured by transvaginal sonography.', 'interventionNames': ['Diagnostic Test: Transvaginal sonography.']}], 'interventions': [{'name': 'Vaginal examination.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cervical properties as evaluated by a vaginal examination.', 'armGroupLabels': ['Classic BISHOP score', 'Modified BISHOP score']}, {'name': 'Transvaginal sonography.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cervical length as evaluated by a transvaginal sonography.', 'armGroupLabels': ['Cervical Length']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam healthcare campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Healthcare Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'ROY LAUTERBACH MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}