Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 5:01 AM
Study NCT ID:
NCT04597333
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Labor Induction After Failed Induction With Dinoprostone.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015232', 'term': 'Dinoprostone'}], 'ancestors': [{'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delivery within 24 hours.', 'timeFrame': 'From the time of induction up to 24 hours from induction.', 'description': 'Rate of delivery in 24 hours.'}, {'measure': 'Time to delivery.', 'timeFrame': 'From the time of induction up to 120 hours from induction.', 'description': 'The number of hours it takes to deliver.'}], 'secondaryOutcomes': [{'measure': 'Mode of delivery.', 'timeFrame': 'From the time of induction up to 120 hours from induction.', 'description': 'Vaginal and cesarean delivery rates.'}, {'measure': 'Uterine revision.', 'timeFrame': 'From the time of induction up to 120 hours from induction.', 'description': 'The rate of uterine revision postpartum.'}, {'measure': 'Postpartum hemorrhage.', 'timeFrame': 'From the time of induction up to 120 hours from induction.', 'description': 'The rate of postpartum hemorrhage.'}, {'measure': 'Chorioamnionitis.', 'timeFrame': 'From the time of induction up to 120 hours from induction.', 'description': 'The rate of chorioamnionitis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Induction of Labor Affected Fetus / Newborn']}, 'descriptionModule': {'briefSummary': 'Women after induction of labor with a dinoprostone insert will be evaluated after 24 hours from the beginning of labor induction. Women with a BISHOP score of less than 5 will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert.', 'detailedDescription': "Nulliparous women with obstetric indications for induction of labor who were induced with a dinoprostone insert and failed to go into labor after 24 hours from the beginning of labor induction and a BISHOP score of less than 5 will receive a thorough explanation regarding the study and sign informed consent. The eligible women will be randomized to 1 of 2 groups. Induction with a cervical ripening balloon versus induction with a 2nd dinoprostone insert. Relevant demographic and medical information will be gathered from the patients' electronic files."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women after induction of labor with Dinoprostone.\n* BISHOP score of under 5 after 1st induction attempt.\n* Nulliparous women.\n\nExclusion Criteria:\n\n* Women after induction of labor with a cervical ripening balloon.\n* BISHOP score of over 5 after 1st induction attempt.\n* Multiparous women.'}, 'identificationModule': {'nctId': 'NCT04597333', 'briefTitle': 'Labor Induction After Failed Induction With Dinoprostone.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Comparison of Cervical Ripening Balloon Versus 2nd Dinoprostone Insert for Labor Induction in Women With a Failed 1st Attempt of Induction With Dinoprostone.', 'orgStudyIdInfo': {'id': '0009-20-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2nd Dinoprostone.', 'description': 'Women induced with a second dinoprostone insert.', 'interventionNames': ['Drug: Dinoprostone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cervical ripening balloon.', 'description': 'Women induced with a cervical ripening balloon.', 'interventionNames': ['Device: Cervical ripening balloon.']}], 'interventions': [{'name': 'Dinoprostone', 'type': 'DRUG', 'description': 'Dinoprostone vaginal insert.', 'armGroupLabels': ['2nd Dinoprostone.']}, {'name': 'Cervical ripening balloon.', 'type': 'DEVICE', 'description': 'Double lumen cervical ripening balloon.', 'armGroupLabels': ['Cervical ripening balloon.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Roy Lauterbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care 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'}}}}