Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 10:58 AM
Study NCT ID:
NCT00674232
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2008-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000027', 'term': 'Abortion, Incomplete'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'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': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D004107', 'term': 'Dilatation and Curettage'}], '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': 'D003475', 'term': 'Curettage'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 311}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-05', 'studyFirstSubmitDate': '2008-04-28', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason', 'timeFrame': 'one week after initial treatment'}], 'secondaryOutcomes': [{'measure': 'side effects', 'timeFrame': 'measured at follow up visit one week after initial treatment'}, {'measure': 'acceptability', 'timeFrame': 'measured at follow up visit one week after initial treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['incomplete abortion', 'spontaneous miscarriage'], 'conditions': ['Incomplete Abortion']}, 'referencesModule': {'references': [{'pmid': '21872244', 'type': 'DERIVED', 'citation': 'Montesinos R, Durocher J, Leon W, Arellano M, Pena M, Pinto E, Winikoff B. Oral misoprostol for the management of incomplete abortion in Ecuador. Int J Gynaecol Obstet. 2011 Nov;115(2):135-9. doi: 10.1016/j.ijgo.2011.06.015. Epub 2011 Aug 26.'}], 'seeAlsoLinks': [{'url': 'http://www.gynuity.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* past or present history of vaginal bleeding during pregnancy\n* open cervical os\n* evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)\n* surgical evacuation of the uterus would be advised as course of action if misoprostol was not available\n* generally in good health\n* woman lives or works within one hour of study site\n* woman willing to provide contact information for follow up purposes\n* informed consent given\n\nExclusion Criteria:\n\n* contraindications to study drug\n* uterine size larger than 12 weeks LMP\n* signs of severe infection'}, 'identificationModule': {'nctId': 'NCT00674232', 'briefTitle': 'Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Misoprostol for Treatment of Incomplete Abortion', 'orgStudyIdInfo': {'id': '2.2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol', 'description': 'Group 1 randomized to take single dose of 600 mcg oral misoprostol', 'interventionNames': ['Drug: 600 mcg misoprostol']}, {'type': 'OTHER', 'label': 'Surgical treatment', 'description': 'Group 2 randomized to receive standard surgical treatment as per local protocol (D\\&C or MVA)', 'interventionNames': ['Procedure: Surgical treatment']}], 'interventions': [{'name': '600 mcg misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': 'single dose of misoprostol taken orally', 'armGroupLabels': ['Misoprostol']}, {'name': 'Surgical treatment', 'type': 'PROCEDURE', 'otherNames': ['D&C, MVA'], 'description': 'Either dilation and curettage or manual vacuum aspiration, as per local protocol', 'armGroupLabels': ['Surgical treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Quito', 'country': 'Ecuador', 'facility': 'Hospital del Dia, CEMOPLAF', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}, {'city': 'Quito', 'country': 'Ecuador', 'facility': 'Hospital Gineco-obstetrico Isidro Ayora', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}, {'city': 'Caracas', 'country': 'Venezuela', 'facility': 'Hospital Maternidad Concepcion Palacios', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'Melanie Peña, MPH, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Jill Durocher', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Beverly Winikoff', 'oldOrganization': 'Gynuity Health Projects'}}}}