Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT00383032
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2006-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-06'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2006-09-28', 'studyFirstSubmitQcDate': '2006-09-29', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'induction to delivery time'}], 'secondaryOutcomes': [{'measure': 'pain'}, {'measure': 'delivery within 24 hours'}, {'measure': 'need for post-partum D&C'}, {'measure': 'adverse events'}]}, 'conditionsModule': {'conditions': ['Abortion, Induced']}, 'referencesModule': {'references': [{'pmid': '17963864', 'type': 'DERIVED', 'citation': 'Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'Data from other countries have suggested that oral mifepristone used as a cervical ripening agent may decrease induction to delivery time in midtrimester inductions. To our knowledge, there are no trials comparing mifepristone to laminaria in a standard clinical setting with standardized misoprostol induction protocol to examine the issue of induction to delivery time. We hypothesize that mifepristone will work at least as well as laminaria for midtrimester cervical ripening prior to induction of labor with misoprostol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with fetal anomalies, aneuploidy, or demise at 15-22 weeks gestation\n* age greater than 16\n* able to speak English\n\nExclusion Criteria:\n\n* prior uterine scar or\n* allergy or history of bad reaction to any of the study drugs or\n* history of chronic adrenal failure or\n* porphyria or\n* concurrent long-term corticosteroid treatment'}, 'identificationModule': {'nctId': 'NCT00383032', 'briefTitle': 'Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction', 'orgStudyIdInfo': {'id': 'CPHS # 16429'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mifepristone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Karen George, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}}}}