Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-03-05 @ 1:49 AM
Study NCT ID:
NCT00355303
Status:
COMPLETED
Last Update Posted:
2015-07-22
First Post:
2006-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D015232', 'term': 'Dinoprostone'}], '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': 'D011458', 'term': 'Prostaglandins E'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 932}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-21', 'studyFirstSubmitDate': '2006-07-19', 'studyFirstSubmitQcDate': '2006-07-20', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caesarean Section rate', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Induction delivery time', 'timeFrame': '48 hours'}, {'measure': 'Neonatal & maternal infectious morbidity', 'timeFrame': '14 days following date of delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Premature rupture of membranes at term', 'Induction of labour', 'Misoprostol', 'PGE2 gel', 'Immediate induction with PGE2 gel', 'Immediate induction with Misoprostol'], 'conditions': ['Premature Rupture of Membranes at Term']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1447-0756', 'label': 'Chaudhuri, S et al. (2011), Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: A randomized comparative trial.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature rupture of membranes at 37 or more weeks\n* Single live fetus in cephalic presentation\n\nExclusion Criteria:\n\n* Women in labour\n* Women with contraindication of induction of labour\n* Women with previous caesarean section or uterine surgery'}, 'identificationModule': {'nctId': 'NCT00355303', 'briefTitle': 'Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nilratan Sircar Medical College'}, 'officialTitle': 'Comparison of Misoprostol and PGE2 Gel for Induction of Labour in in Premature Rupture of Membranes at Term- A Randomized Comparative Trial', 'orgStudyIdInfo': {'id': '2-Chaudhuri'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol tablet, PGE2 gel', 'description': 'participants are assigned to one of two arms for the duration of the study In one group induction of labour is done by intravaginal misoprostol tablets at 4 hrly interval with maximum of five doses.In other group PGE2 gel is applied in poaterior fornix at six hourly interval.', 'interventionNames': ['Drug: Misoprostol', 'Drug: PGE2 gel']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'otherNames': ['Misoprost'], 'description': 'Vaginal application of Misoprostol tablets at 4 hrly interval with maximumof five doses', 'armGroupLabels': ['Misoprostol tablet, PGE2 gel']}, {'name': 'PGE2 gel', 'type': 'DRUG', 'otherNames': ['Dinoprostone gel'], 'description': 'PGE2 gel will be applied in poaterior fornix at six hrly interval with maximum of 2 doses', 'armGroupLabels': ['Misoprostol tablet, PGE2 gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700014', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Nilratan Sircar Medical College, 138,AJC Bose Road,', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}], 'overallOfficials': [{'name': 'Snehamay Chaudhuri, MBBS,MD.DNB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nilratan Sircar Medical College , Kolkata, West bengal , India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nilratan Sircar Medical College', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor , Obstetrics and Gynecology, NRS Medical College', 'investigatorFullName': 'Dr Snehamay Chaudhuri', 'investigatorAffiliation': 'Nilratan Sircar Medical College'}}}}