Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-01 @ 8:32 PM
Study NCT ID:
NCT02196103
Status:
UNKNOWN
Last Update Posted:
2014-07-21
First Post:
2014-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Labor in Patients With Previous Cesarian Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2014-07-15', 'studyFirstSubmitQcDate': '2014-07-17', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'satisfaction', 'timeFrame': '48 hours', 'description': 'maternal experience and satisfaction with the method of delivery that was applied'}], 'primaryOutcomes': [{'measure': 'vaginal delivery rate', 'timeFrame': '48 hours', 'description': '20% higher vaginal delivery rate'}], 'secondaryOutcomes': [{'measure': 'safety', 'timeFrame': '48 hours', 'description': 'safety of the double balloon device in women with one previous cesarian section and PROM at \\>/=34 weeks by monitoring fetal heart rate, increased uterine hemorrhage, maternal hemodinamic changes, and uterine atony.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TOLAC', 'PROM', 'Previous Cesarian section', 'Mechanical cervical ripening'], 'conditions': ['Pregnancy', 'Previous Cesarian Section', 'Premature Rupture of Membranes (PROM)']}, 'referencesModule': {'references': [{'pmid': '36996264', 'type': 'DERIVED', 'citation': 'de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.'}]}, 'descriptionModule': {'briefSummary': 'Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed to be pregnant with PROM at \\>34 weeks. Rupture of membranes will be determine clinically and confirmed by positive Nitrazine test.\n* Ruptured membranes have occurred in the last 24 hours prior to inclusion in the study.\n* Found to have an unripe cervix in a speculum examination.\n* Singleton pregnancy in a vertex presentation well applied to the cervix and absence of significant and regular uterine contractions (3-5/10 Min)\n* Previous on cesarian section.\n* Willingness to comply with the protocol for the duration of the study.\n* Have signed an informed consent.\n\nExclusion Criteria: Patients having any of the following conditions:\n\n* Any contraindication for the vaginal delivery (i.e. placenta previa, non vertex presentation).\n* Regular uterine contractions (3-5/10 min).\n* Diagnosis of rupture membranes was made over 24 hours prior the study inclusion.\n* Evidence of chorio-amnionitis (T 37.6 celsious Degree with uterine tenderness and maternal or fetal tachycardia or purulent discharge or WBC\\>/=20,000)\n* Suspected placental abruption or presence of a significant hemorrhage.\n* Non-reassuring fetal status (as determined by fetal heart rate monitoring and/or bio-physical profile) necessitating immediate intervention.'}, 'identificationModule': {'nctId': 'NCT02196103', 'briefTitle': 'Management of Labor in Patients With Previous Cesarian Section', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Management of Labor in Patients With Previous Cesarian Section and Premature Rupture of Membranes Who Desire TOLAC: Comparison Between the Use of Standard Expectant Management and the Double-balloon Catheter Device. A Prospective Randomized Study', 'orgStudyIdInfo': {'id': '0019-14-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expectant management', 'interventionNames': ['Device: Double balloon cervical catheter']}], 'interventions': [{'name': 'Double balloon cervical catheter', 'type': 'DEVICE', 'armGroupLabels': ['Expectant management']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Asnat Walfisch, MD', 'role': 'CONTACT', 'phone': '050-4492200'}], 'overallOfficials': [{'name': 'Asnat Walfisch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}