Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT01811056
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2013-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-11', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-13', 'lastUpdatePostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Productivity', 'timeFrame': '1-2 weeks', 'description': 'Missed days of school and/or work Additional costs for childcare or eldercare'}, {'measure': 'Reasons for selection of mifepristone administration site and experiences with home administration Reason', 'timeFrame': '1-2 weeks', 'description': 'Reasons for selection of mifepristone administration site and experiences with home administration'}], 'primaryOutcomes': [{'measure': 'Proportion of participants who would choose outside of center administration of mifepristone again', 'timeFrame': '1-2 weeks'}, {'measure': 'Proportion of participants who would recommend outside-of-center administration to a friend', 'timeFrame': '1-2 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of women who select outside-of-clinic use of mifepristone', 'timeFrame': '1-2 weeks'}, {'measure': 'Success Rates/Method Failure', 'timeFrame': '1-2 weeks', 'description': 'Ongoing pregnancy at study end Incomplete abortion at study end Medically indicated surgical intervention during study'}, {'measure': 'Adherence', 'timeFrame': '1-2 weeks', 'description': 'Did not take complete therapy Mifepristone not taken at scheduled time Mifepristone not taken within 63 days L.M.P. Misoprostol not taken within 48 hours of mifepristone administration Did not return for confirmation of outcome'}, {'measure': 'Provider-related outcomes', 'timeFrame': '1-2 weeks', 'description': 'Unscheduled visits to center Unscheduled calls to center/clinician on-call Provider satisfaction- better than center mifepristone, equivalent, or worse; impact on workload; impact on quality of care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['medical abortion', 'mifepristone'], 'conditions': ['Termination of Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23177917', 'type': 'BACKGROUND', 'citation': 'Swica Y, Chong E, Middleton T, Prine L, Gold M, Schreiber CA, Winikoff B. Acceptability of home use of mifepristone for medical abortion. Contraception. 2013 Jul;88(1):122-7. doi: 10.1016/j.contraception.2012.10.021. Epub 2012 Nov 21.'}, {'pmid': '26142620', 'type': 'RESULT', 'citation': 'Chong E, Frye LJ, Castle J, Dean G, Kuehl L, Winikoff B. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S. Contraception. 2015 Sep;92(3):215-9. doi: 10.1016/j.contraception.2015.06.026. Epub 2015 Jul 2.'}], 'seeAlsoLinks': [{'url': 'http://www.gynuity.org', 'label': 'Gynuity Health Projects Website'}]}, 'descriptionModule': {'briefSummary': 'This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.', 'detailedDescription': 'This study will investigate the uptake of mifepristone administration outside of the health center for pregnancy termination and its acceptability to women and to their providers. In addition, we plan to evaluate rates of follow-up, adherence, efficacy, complications, days of missed work and/or school, and lost income. This will be a prospective, comparative, non-randomized, open-label study. All women who are seeking medical abortion will be offered participation in the study. Women who enroll in the study will be given a choice between taking the mifepristone outside the center or in the center setting.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 years and older\n* seeking medical abortion services\n* in general good health\n* assessed by a clinician to have an intrauterine pregnancy less than 64 days L.M.P on the day mifepristone will be taken\n* eligible for medical abortion according to clinician and center standards.\n\nExclusion Criteria:\n\n* will be followed up by beta HCG and not ultrasound'}, 'identificationModule': {'nctId': 'NCT01811056', 'briefTitle': 'Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion', 'orgStudyIdInfo': {'id': '1006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'In-Center Use of Mifepristone', 'description': 'Participants who choose to take mifepristone in the center'}, {'type': 'EXPERIMENTAL', 'label': 'Out-of-Center Use of Mifepristone', 'description': 'Participants who choose to take the mifepristone outside of the center', 'interventionNames': ['Drug: Mifepristone']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'otherNames': ['mifeprex'], 'description': 'Mifepristone use outside of the center', 'armGroupLabels': ['Out-of-Center Use of Mifepristone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Planned Parenthood of New York City', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Barre, Burlington, Rutland', 'state': 'Vermont', 'country': 'United States', 'facility': 'Planned Parenthood of Northern New England'}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Planned Parenthood of the Great Northwest', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}