Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT00355966
Status:
COMPLETED
Last Update Posted:
2010-03-25
First Post:
2006-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term
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'}]}, '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-24', 'studyFirstSubmitDate': '2006-07-18', 'studyFirstSubmitQcDate': '2006-07-24', 'lastUpdatePostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission to delivery time', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Caesarean Section rate', 'timeFrame': '48 hours'}, {'measure': 'Neonatal morbidity', 'timeFrame': 'Till discharge'}, {'measure': 'Maternal morbidity', 'timeFrame': 'Till discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Premature rupture of membranes', 'Induction of labour with Misoprostol', 'Induction of labour with PGE2 gel'], 'conditions': ['Premature Rupture of Membranes at Term']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://medind.nic.in/jaq/t06/i3/jaqt06i3p224.pdf', 'label': 'Chaudhuri S, Mitra SN, Biswas PK, Bhattcharyya S.Pramature rupture of membranes at term: Immediate induction with PGE2 gel compared with delayed induction with oxytocin,Ind J Obstet Gynecol Vol56,no 3; 2006,224-229'}]}, 'descriptionModule': {'briefSummary': 'Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.'}, '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': 'NCT00355966', 'briefTitle': 'Comparison of Misoprostol and PGE2 Gel for Induction of Labour in Women With Premature Rupture of Membranes at Term', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nilratan Sircar Medical College'}, 'officialTitle': 'Comparison of Misorostol & PGE2 Gel for Immediate Induction of Labour for Premature Ropture of Membranes at Term', 'orgStudyIdInfo': {'id': '1-Chaudhuri'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'In Group B immediate induction of labour will be done by application of vaginal PGE2 gel 0.5 gm at an interval of 6 hours , a maximum of 2 doses.', 'interventionNames': ['Drug: PGE2 gel']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'description': 'In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .', 'armGroupLabels': ['A']}, {'name': 'PGE2 gel', 'type': 'DRUG', 'description': 'In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700014', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'NRS Medicl College,138 AJC Bose Road', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}], 'overallOfficials': [{'name': 'Snehamay Chaudhuri, MBBS,MD,DNB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NRS Medical College , Kolkata, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nilratan Sircar Medical College', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Chairperson of Ethical Committee & Principal', 'oldOrganization': 'Nilratan Sircar Medical College , Kolkata'}}}}