Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-29 @ 3:01 PM
Study NCT ID:
NCT02570204
Status:
COMPLETED
Last Update Posted:
2017-05-01
First Post:
2015-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059026', 'term': 'Diagnostic Self Evaluation'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-28', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who fail to contact the clinic when indicated within two weeks after taking the mifepristone', 'timeFrame': 'One month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Medical Abortion']}, 'referencesModule': {'references': [{'pmid': '29242085', 'type': 'DERIVED', 'citation': 'Raymond EG, Tan YL, Grant M, Benavides E, Reis M, Sacks DN, Hannum C, Frapp S, Weaver MA. Self-assessment of medical abortion outcome using symptoms and home pregnancy testing. Contraception. 2018 Apr;97(4):324-328. doi: 10.1016/j.contraception.2017.12.004. Epub 2017 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effectiveness and acceptability of the multi-level pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '56 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Gestational age of less than or equal to 63 days\n* Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria\n* Willing to use the MLPT at home\n* 11-56 years old\n* Willing and able to comply with study procedures\n* In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT02570204', 'briefTitle': 'Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests', 'orgStudyIdInfo': {'id': '1033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-assessment of abortion outcome', 'description': 'Patients enrolled in the study will self-assess the outcomes of their medical abortion with the aid of a multi-level pregnancy test (MLPT) which they will perform at home.', 'interventionNames': ['Behavioral: Self-assessment']}], 'interventions': [{'name': 'Self-assessment', 'type': 'BEHAVIORAL', 'description': 'Patients enrolled into the study will do a multi-level pregnancy test (MLPT) at enrollment, and will receive one MLPT to do at home one week after taking mifepristone and misoprostol. They will be instructed to call the study site if the at-home MLPT result do not decline, or if they experience any abortion complications.', 'armGroupLabels': ['Self-assessment of abortion outcome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Presidential Women's Center", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Carafem', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Philadelphia Women's Center", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Elizabeth Raymond, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}