Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT02649920
Status:
TERMINATED
Last Update Posted:
2024-08-15
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'guillaume.ducarme@ght85.fr', 'phone': '02 51 44 61 61', 'title': 'Dr. Guillaume DUCARME', 'organization': 'Centre Hospitalier Départemental Vendée'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Death, serious adverse event and other (non serious adverse event) were not assessed for the study', 'eventGroups': [{'id': 'EG000', 'title': 'Cervical Ripening Balloon', 'description': 'Prospective\n\nCervical ripening balloon', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dinoprostone', 'description': 'Retrospective\n\nDinoprostone', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bishop Score After 24 Hours of Maturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervical Ripening Balloon', 'description': 'Prospective\n\nCervical ripening balloon'}, {'id': 'OG001', 'title': 'Dinoprostone', 'description': 'Retrospective\n\nDinoprostone'}], 'timeFrame': '24 hours', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervical Ripening Balloon', 'description': 'Prospective\n\nCervical ripening balloon'}, {'id': 'FG001', 'title': 'Dinoprostone', 'description': 'Retrospective\n\nDinoprostone'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervical Ripening Balloon', 'description': 'Prospective\n\nCervical ripening balloon'}, {'id': 'BG001', 'title': 'Dinoprostone', 'description': 'Retrospective\n\nDinoprostone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '2.12', 'groupId': 'BG000'}, {'value': '26.5', 'spread': '2.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The sponsor took the decision to stop the inclusions prematurely as of 23/11/2016. No statistical analysis was performed.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The sponsor took the decision to stop the inclusions prematurely as of 23/11/2016. No statistical analysis was performed.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The sponsor took the decision to stop the inclusions prematurely as of 23/11/2016. No statistical analysis was performed.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Delayed inclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2016-01-04', 'resultsFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-15', 'studyFirstPostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bishop Score After 24 Hours of Maturation', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['unfavorable cervix', 'obese pregnant women'], 'conditions': ['Delivery']}, 'descriptionModule': {'briefSummary': 'At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature.\n\nThere is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®).\n\nOther methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®).\n\nThe population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures.\n\nThe investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Term ≥ 37 weeks of amenorrhea\n* Singleton pregnancy\n* Cephalic presentation\n* Medical indication of release and unfavorable cervix (Bishop \\<6)\n* BM pre-pregnancy ≥ 30 kg/m2\n* Having given their agreement for the participation of the study\n* Patient receiving social coverage\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Term \\< 37 weeks of amenorrhea\n* Multiple pregnancy\n* Favorable cervix (Bishop ≥ 6)\n* Contraindication of vaginal delivery: praevia placenta, transverse presentation, cord prolapse\n* Evolutive urinary tract infection (positive urine dip: leukocytes/ nitrites)\n* Not affiliated with a legal protection regime\n* Patient trust, guardianship, under legal protection measure, deprived of freedom\n\nBalloon's contraindications:\n\n* Abnormal pelvis structure\n* Evolutive genital herpes\n* Invasive cervical cancer\n* Anomaly of foetal heart rate\n* Breech presentation\n* Maternal heart disorder\n* Hydramnios\n* Serious and uncontrolled arterial high blood pressure\n* Rupture of membranes\n* Medical histories of hysterotomy, classic uterine section, myomectomy or quite different uterine section of full thickness\n* Presentation above superior pelvic strait\n\nDinoprostone's contraindications:\n\n* Scarred uterus\n* Prostaglandin's hypersensitivity"}, 'identificationModule': {'nctId': 'NCT02649920', 'acronym': 'BALLODINO', 'briefTitle': 'Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Departemental Vendee'}, 'officialTitle': 'Pilot, Comparative, Not Randomized, Two Centers Study Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)', 'orgStudyIdInfo': {'id': 'CHD019-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical ripening balloon', 'description': 'Prospective', 'interventionNames': ['Device: Cervical ripening balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dinoprostone', 'description': 'Retrospective', 'interventionNames': ['Drug: Dinoprostone']}], 'interventions': [{'name': 'Cervical ripening balloon', 'type': 'DEVICE', 'otherNames': ['Cook'], 'armGroupLabels': ['Cervical ripening balloon']}, {'name': 'Dinoprostone', 'type': 'DRUG', 'otherNames': ['Propess'], 'armGroupLabels': ['Dinoprostone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'Centre Hospitalier Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Hospitalier', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'overallOfficials': [{'name': 'Guillaume DUCARME, PH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Departemental Vendee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Departemental Vendee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}