Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-02-22 @ 8:10 AM
Study NCT ID:
NCT00529295
Status:
COMPLETED
Last Update Posted:
2007-09-14
First Post:
2007-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-13', 'studyFirstSubmitDate': '2007-09-13', 'studyFirstSubmitQcDate': '2007-09-13', 'lastUpdatePostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes.', 'timeFrame': 'within the first week after delivery'}], 'secondaryOutcomes': [{'measure': 'Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure.', 'timeFrame': 'The days during induction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['misoprostol', 'labor induction'], 'conditions': ['Labor Induction']}, 'referencesModule': {'references': [{'pmid': '11563466', 'type': 'RESULT', 'citation': 'Hofmeyr GJ, Alfirevic Z, Matonhodze B, Brocklehurst P, Campbell E, Nikodem VC. Titrated oral misoprostol solution for induction of labour: a multi-centre, randomised trial. BJOG. 2001 Sep;108(9):952-9. doi: 10.1111/j.1471-0528.2001.00231.x.'}, {'pmid': '34155622', 'type': 'DERIVED', 'citation': 'Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.'}, {'pmid': '18165400', 'type': 'DERIVED', 'citation': 'Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):119-25. doi: 10.1097/01.AOG.0000297313.68644.71.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.', 'detailedDescription': 'Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 34 to 42 weeks of gestation\n* live singleton\n* Bishop score \\< or = 6\n* reassuring fetal heart beat pattern\n\nExclusion Criteria:\n\n* nonreassuring fetal heart beat pattern\n* parity ovr five\n* any contraindication to labor and/or vaginal delivery\n* uterine scar\n* suspected placental abruption with abnormal FHR pattern\n* vaginal bleeding other than "bloody show"\n* cervical dilatation of \\> or = 4 cm\n* uterine contractions \\> or = 3 in 10 minutes\n* significant maternal cardiac, renal or hepatic disease\n* hypersensitivity to misoprostol or prostaglandin analogs'}, 'identificationModule': {'nctId': 'NCT00529295', 'briefTitle': 'Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'orgStudyIdInfo': {'id': 'DMR95-IRB-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Titrated oral misoprostol', 'interventionNames': ['Drug: misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Vaginal misoprostol', 'interventionNames': ['Drug: misoprostol']}], 'interventions': [{'name': 'misoprostol', 'type': 'DRUG', 'description': 'Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '651', 'city': 'Douliu', 'country': 'Taiwan', 'facility': 'China Medical University Beigang Hospital', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}], 'overallOfficials': [{'name': 'Shi-Yann Cheng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinal Medical University Beigang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}}}}