Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-25 @ 6:47 AM
Study NCT ID:
NCT00994734
Status:
COMPLETED
Last Update Posted:
2012-04-17
First Post:
2009-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-05-15', 'releaseDate': '2013-03-18'}], 'estimatedResultsFirstSubmitDate': '2013-03-18'}}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 615}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-16', 'studyFirstSubmitDate': '2009-10-09', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2012-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women who select home-use of mifepristone', 'timeFrame': '1-2 weeks'}, {'measure': 'Satisfaction with Method', 'timeFrame': '1-2 weeks'}]}, 'conditionsModule': {'conditions': ['Termination of Pregnancy']}, 'referencesModule': {'references': [{'pmid': '25482435', 'type': 'DERIVED', 'citation': 'Conkling K, Karki C, Tuladhar H, Bracken H, Winikoff B. A prospective open-label study of home use of mifepristone for medical abortion in Nepal. Int J Gynaecol Obstet. 2015 Mar;128(3):220-3. doi: 10.1016/j.ijgo.2014.09.022. Epub 2014 Nov 27.'}]}, 'descriptionModule': {'briefSummary': "The primary aim of this study is to assess the acceptability of home-use mifepristone for termination of pregnancy among women who choose it and their providers. The investigators' secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost productivity, and to estimate the minimum proportion of women who choose home-use over clinic use of mifepristone."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reproductive age women seeking abortion services.\n* Eligible women will be in general good health and assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken.\n* Participants must be eligible for medical abortion according to clinician and clinic standards.\n* In the United States, women only 18 years and older will be eligible to participate, unless the study site obtains a waiver to include minors.'}, 'identificationModule': {'nctId': 'NCT00994734', 'briefTitle': 'Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion', 'orgStudyIdInfo': {'id': '1.2.3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'clinic administration of mifepristone'}, {'type': 'EXPERIMENTAL', 'label': 'home administration of mifepristone', 'interventionNames': ['Drug: Mifepristone']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'home administration of mifepristone', 'armGroupLabels': ['home administration of mifepristone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Feminist Women's Health Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Institute for Family Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Family Health Center, Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Municipal Clinical Hospital', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Kathmandu', 'country': 'Nepal', 'facility': 'Kathmandu Medical College', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}, {'city': 'Kathmandu', 'country': 'Nepal', 'facility': 'Nepal Medical College Teaching Hospital', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-03-18', 'type': 'RELEASE'}, {'date': '2013-05-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gynuity Health Projects'}}}}