Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT00886860
Status:
COMPLETED
Last Update Posted:
2010-07-14
First Post:
2009-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-12', 'studyFirstSubmitDate': '2009-04-22', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2010-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate of cervical ripening in labor induction', 'timeFrame': '12 hours after intervention'}], 'secondaryOutcomes': [{'measure': 'number of vaginal delivery', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Efficacy', 'Cervical ripening/Labor induction', 'Titrated oral misoprostol/Conventional oral misoprostol', 'Term pregnancy'], 'conditions': ['Cervical Ripening', 'Labor Induction']}, 'referencesModule': {'references': [{'pmid': '21959071', 'type': 'DERIVED', 'citation': 'Thaisomboon A, Russameecharoen K, Wanitpongpan P, Phattanachindakun B, Changnoi A. Comparison of the efficacy and safety of titrated oral misoprostol and a conventional oral regimen for cervical ripening and labor induction. Int J Gynaecol Obstet. 2012 Jan;116(1):13-6. doi: 10.1016/j.ijgo.2011.07.027. Epub 2011 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years old or more\n* singleton pregnancy at 37 weeks gestation or more\n* cephalic presentation\n* reassuring fetal heart rate pattern\n* admission for labor induction due to medical or obstetrical conditions\n* bishop score less than 6\n* giving consent and having signed the consent form for this study\n\nExclusion Criteria:\n\n* parity more than 3\n* estimated fetal weight more than 3,500 grams\n* non-reassuring fetal heart rate pattern\n* having contraindication for vaginal delivery\n* previous uterine scar\n* suspected abruptio placenta with non-reassuring fetal heart rate pattern\n* abnormal bleeding per vagina, except bloody show\n* PROM\n* having underlying cardiac, hepatic, or renal diseases\n* having history of allergy to misoprostol or prostaglandin analogues\n* cervical dilatation 3 centimeters or more\n* uterine contraction 3 times or more in 10 minute'}, 'identificationModule': {'nctId': 'NCT00886860', 'briefTitle': 'The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol', 'orgStudyIdInfo': {'id': '091/2552(EC2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional oral misoprostol', 'description': 'misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters', 'interventionNames': ['Drug: misoprostol']}, {'type': 'EXPERIMENTAL', 'label': 'titrated oral misoprostol', 'description': 'misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters', 'interventionNames': ['Drug: misoprostol']}], 'interventions': [{'name': 'misoprostol', 'type': 'DRUG', 'otherNames': ['cytotec'], 'description': 'misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm', 'armGroupLabels': ['conventional oral misoprostol']}, {'name': 'misoprostol', 'type': 'DRUG', 'otherNames': ['cytotec'], 'description': 'misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm', 'armGroupLabels': ['titrated oral misoprostol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Kusol Russameecharoen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kusol Russameecharoen, MD.', 'oldOrganization': 'Faculty of Medicine Siriraj Hospital, Mahidol University'}}}}