Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-08 @ 5:15 PM
Study NCT ID:
NCT00501033
Status:
COMPLETED
Last Update Posted:
2008-05-08
First Post:
2007-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004716', 'term': 'Endometritis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058582', 'term': 'Double-Balloon Enteroscopy'}], 'ancestors': [{'id': 'D000071087', 'term': 'Balloon Enteroscopy'}, {'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-02', 'studyFirstSubmitDate': '2007-07-12', 'studyFirstSubmitQcDate': '2007-07-12', 'lastUpdatePostDateStruct': {'date': '2008-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of labor induction', 'timeFrame': 'Postpartum period'}], 'secondaryOutcomes': [{'measure': 'Postpartum endometritis rate', 'timeFrame': 'The postpartum period'}, {'measure': 'Cesarean section rate', 'timeFrame': 'Delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Induction of labor', 'Cesarean', 'Endometritis', 'Foley', 'Infections'], 'conditions': ['Induction of Labor', 'Cesarean', 'Endometritis']}, 'referencesModule': {'references': [{'pmid': '31185762', 'type': 'DERIVED', 'citation': 'Solt I, Frank Wolf M, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley catheter versus cervical double balloon for labor induction: a prospective randomized study. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1034-1041. doi: 10.1080/14767058.2019.1623776. Epub 2019 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.', 'detailedDescription': 'We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term pregnancy\n* Parturients candidates for mechanical induction of labor\n\nExclusion Criteria:\n\n* Suspected amnionitis\n* Vaginal discharge\n* Pre induction pyrexia\n* Immunocompromised parturients'}, 'identificationModule': {'nctId': 'NCT00501033', 'briefTitle': 'A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Western Galilee Hospital-Nahariya'}, 'officialTitle': 'A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter', 'orgStudyIdInfo': {'id': '4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mechanical induction of labor', 'type': 'DEVICE'}, {'name': 'Double Balloon', 'type': 'DEVICE'}, {'name': 'Foley Catheter', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Western Galilee Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}], 'overallOfficials': [{'name': 'Ido Solt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Galilee Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Galilee Hospital-Nahariya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Professor Jacob Bornstein', 'oldOrganization': 'Western Galilee Hospital'}}}}