Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 9:43 PM
Study NCT ID:
NCT00602095
Status:
COMPLETED
Last Update Posted:
2008-01-28
First Post:
2008-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Labour Induction With Misoprostol, Dinoprostone and Bard Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D015232', 'term': 'Dinoprostone'}, {'id': 'C010714', 'term': 'dinoprost tromethamine'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'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'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D011458', 'term': 'Prostaglandins E'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-15', 'studyFirstSubmitDate': '2008-01-02', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from treatment start to delivery', 'timeFrame': 'At delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Labor induction', 'cervical ripening', 'misoprostol', 'dinoprostone', 'balloon catheter', 'prostaglandin'], 'conditions': ['Pregnancy']}, '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': 'This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.\n\nThe main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term singleton pregnancy with vertex presentation and with an indication for labour induction.\n* Absence of active labour\n* Bishop score ≤ 6.\n* Normal CTG registration\n\nExclusion Criteria:\n\n* Previous cesarean section\n* signs of infection\n* immediate need for delivery\n* any contraindication for vaginal delivery'}, 'identificationModule': {'nctId': 'NCT00602095', 'acronym': 'LI', 'briefTitle': 'Labour Induction With Misoprostol, Dinoprostone and Bard Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction', 'orgStudyIdInfo': {'id': 'LMS2007'}, 'secondaryIdInfos': [{'id': 'KS2007'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Labour induction with misoprostol', 'interventionNames': ['Drug: misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Labour induction with dinoprostone', 'interventionNames': ['Drug: dinoprostone']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Labour induction with bard', 'interventionNames': ['Device: Bard Catheter (balloon catheter)']}], 'interventions': [{'name': 'misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec, one quarter of a 0.100mg tablet'], 'description': '0.025mg tablet vaginally every 4 hour until progress', 'armGroupLabels': ['1']}, {'name': 'dinoprostone', 'type': 'DRUG', 'otherNames': ['Minprostin'], 'description': '2mg vaginal gel every 6 hours until progress', 'armGroupLabels': ['2']}, {'name': 'Bard Catheter (balloon catheter)', 'type': 'DEVICE', 'otherNames': ['Bard Catheter'], 'description': 'Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lena Marions, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Lena Marions MD PhD', 'oldOrganization': 'Karolinska University Hospital'}}}}