Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT00670761
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2008-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol for the Treatment of Incomplete Abortion
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'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2008-04-29', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, '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 with the option of an additional week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['misoprostol', 'incomplete abortion', 'sublingual', 'postabortion care', 'MVA'], 'conditions': ['Abortion, Incomplete']}, 'referencesModule': {'references': [{'pmid': '23697561', 'type': 'DERIVED', 'citation': 'Ngoc NT, Shochet T, Blum J, Hai PT, Dung DL, Nhan TT, Winikoff B. Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting. BMC Pregnancy Childbirth. 2013 May 22;13:118. doi: 10.1186/1471-2393-13-118.'}]}, 'descriptionModule': {'briefSummary': 'This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.\n\nWomen diagnosed with incomplete abortion will be randomized to receive one of the following regimens:\n\nIn Tanzania and Mozambique:\n\n1. 600 mcg of oral misoprostol in one dose, or\n2. Standard surgical treatment (MVA)\n\nIn Moldova and Madagascar:\n\n1. 600 mcg of oral misoprostol in one dose, or\n2. 400 mcg of sublingual misoprostol in one dose.\n\nIn Burkina Faso and Vietnam:\n\n1\\. 400 mcg of sublingual misoprostol in one dose.\n\nWe hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* If no ultrasound used:\n\n 1. Past or present history of vaginal bleeding during pregnancy; and\n 2. Open cervical os.\n* If ultrasound used:\n\n 1. Past or present history of vaginal bleeding during pregnancy; and\n 2. Evidence of incomplete abortion with substantial debris in the uterus.\n\nAll women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.\n\n* Willing to provide contact information for purposes of follow-up.\n\n * In Tanzania: 18 years of age or over or parental permission\n * In Mozambique: 21 years of age or over or parental permission\n * In Moldova: 18 years of age or over\n * In Madagascar: 18 years of age or parental permission\n * In Vietnam: reproductive age\n\nExclusion Criteria:\n\n* Contraindications to the study drug;\n* Uterine size larger than 12 weeks L.M.P. at time of presentation for care.\n* Signs of severe infection, defined as at least one of the following of:\n\n 1. foul smelling discharge,\n 2. fever \\> 39 degrees C ,\n 3. pulse \\>110/min;'}, 'identificationModule': {'nctId': 'NCT00670761', 'briefTitle': 'Misoprostol for the Treatment of Incomplete Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options', 'orgStudyIdInfo': {'id': '2.2.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'treatment with 600mcg oral misoprostol', 'interventionNames': ['Drug: misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'treatment with 400mcg sublingual misoprostol', 'interventionNames': ['Drug: misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'treatment with Manual Vacuum Aspiration (MVA)', 'interventionNames': ['Procedure: MVA']}], 'interventions': [{'name': 'misoprostol', 'type': 'DRUG', 'otherNames': ['Cytotec'], 'description': 'comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)', 'armGroupLabels': ['1', '2']}, {'name': 'MVA', 'type': 'PROCEDURE', 'description': 'comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bobo-Dioulasso', 'country': 'Burkina Faso', 'facility': 'Hôpital de District Sanitaire Dandé', 'geoPoint': {'lat': 11.18064, 'lon': -4.29489}}, {'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Hôpital de District Sanitaire de Ziniaré', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Antananarivo', 'country': 'Madagascar', 'facility': 'Befelatanana Maternity Centre', 'geoPoint': {'lat': -18.91368, 'lon': 47.53613}}, {'city': 'Chishinau', 'country': 'Moldova', 'facility': 'Municipal Clinical Hospital'}, {'city': 'Maputo', 'country': 'Mozambique', 'facility': 'Jose Macamo Hospital', 'geoPoint': {'lat': -25.96553, 'lon': 32.58322}}, {'city': 'Bukoba', 'country': 'Tanzania', 'facility': 'Kagera Regional Hospital', 'geoPoint': {'lat': -1.33167, 'lon': 31.81222}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'collaborators': [{'name': 'Befelatanana Maternity Centre', 'class': 'UNKNOWN'}, {'name': 'Municipal Clinical Hospital No. 1', 'class': 'UNKNOWN'}, {'name': 'Kagera Regional Hospital', 'class': 'OTHER'}, {'name': 'Jose Macamo Hospital', 'class': 'UNKNOWN'}, {'name': 'Tudu hospital', 'class': 'UNKNOWN'}, {'name': 'National OBGYN hospital', 'class': 'UNKNOWN'}, {'name': 'Cuchi General District hospital', 'class': 'UNKNOWN'}, {'name': 'Hôpital de District Sanitaire Dandé', 'class': 'UNKNOWN'}, {'name': 'Hôpital de District Sanitaire de Ziniaré', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}