Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT01711060
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2012-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-10', 'studyFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2012-10-19', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of childbirth by low way', 'description': 'The childbirth by low way being considered as a success of the treatment'}], 'secondaryOutcomes': [{'measure': 'Rate of incidence of materno-fœtales morbidity', 'description': 'number'}]}, 'conditionsModule': {'conditions': ['Scarred Uterus']}, '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': "Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.\n\nIntracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.\n\nBut it was rarely tested on women with scared uterus and unfavorable cervix (bishop score \\<4).\n\nThe investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).\n\nThe investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy over 37 weeks\n* Singleton pregnancy\n* Vertex presentation\n* Previous caesarean section with unique Transversal segmentary incision\n* Medical indication of induction of labor\n* Unfavorable cervix with Bishop score \\< 4\n* No Premature Rupture Of Membranes\n* Informed consent\n\nExclusion Criteria:\n\n* Before 18 years old\n* Placenta Praevia\n* Premature Rupture Of Membranes\n* Uterine scar other than transversal segmentary incision\n* Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis\n* Multiple pregnancy\n* Fetal malpresentation\n* Cesarean indication\n* Latex allergy\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT01711060', 'briefTitle': 'A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'CICATAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oxytocin', 'interventionNames': ['Drug: oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'balloon catheter', 'description': 'Dufour 1859H18', 'interventionNames': ['Procedure: balloon catheter']}], 'interventions': [{'name': 'oxytocin', 'type': 'DRUG', 'armGroupLabels': ['oxytocin']}, {'name': 'balloon catheter', 'type': 'PROCEDURE', 'armGroupLabels': ['balloon catheter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angoulême', 'country': 'France', 'facility': 'Service Gynécologie Obstétrique', 'geoPoint': {'lat': 45.64997, 'lon': 0.15345}}, {'city': 'Bressuire', 'country': 'France', 'facility': 'Service Gynécologie Obstétrique', 'geoPoint': {'lat': 46.84158, 'lon': -0.49042}}, {'city': 'Châtellerault', 'country': 'France', 'facility': 'Service Gynécologie Obstétrique', 'geoPoint': {'lat': 46.81705, 'lon': 0.54518}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Service Gynécologie Obstétrique', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Service Gynécologie Obstétrique et médecine de la reproduction', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Service Gynécologie Obstétrique', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Service Gynécologie Obstétrique', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}