Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-24 @ 8:00 AM
Study NCT ID:
NCT03014193
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2017-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simplifying First Trimester Medical Abortion Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2017-01-05', 'studyFirstSubmitQcDate': '2017-01-05', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding of the instructions for the multilevel pregnancy test', 'timeFrame': '14 days'}, {'measure': 'Ability to independently use the multilevel pregnancy tests', 'timeFrame': '14 days'}, {'measure': 'Ability to interpret the results of the multilevel pregnancy test', 'timeFrame': '14 days'}]}, 'conditionsModule': {'conditions': ['Medical Abortion']}, 'descriptionModule': {'briefSummary': 'This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women seeking medical abortion with pregnancies of 63 days or less.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a first trimester pregnancy with a gestational age of ≤63 days;\n* Desire medical abortion with mifepristone and misoprostol and be medically eligible for that treatment, according to clinic protocol;\n* Be able to read and understand the local language or Russian;\n* Have access to a telephone;\n* Agree to follow all study procedures;\n* Have no contraindication to participation in the study, in the judgment of the site investigator or designee.'}, 'identificationModule': {'nctId': 'NCT03014193', 'briefTitle': 'Simplifying First Trimester Medical Abortion Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Simplifying First Trimester Medical Abortion Follow-up', 'orgStudyIdInfo': {'id': '6009'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Semiquantitative Multi-Level Pregnancy Test', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyumri', 'country': 'Armenia', 'facility': 'Gyumri Maternity Hospital', 'geoPoint': {'lat': 40.79305, 'lon': 43.84635}}, {'city': 'Yerevan', 'country': 'Armenia', 'facility': 'Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Batumi', 'country': 'Georgia', 'facility': 'Batumi International Hospital', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'David Gagua Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'City Policlinic #17', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}