Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-08 @ 1:53 AM
Study NCT ID:
NCT02415894
Status:
COMPLETED
Last Update Posted:
2016-07-22
First Post:
2015-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful abortion', 'timeFrame': '15 hours after start of misoprostol induction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Other Abortion']}, 'referencesModule': {'references': [{'pmid': '31164394', 'type': 'DERIVED', 'citation': 'Platais I, Tsereteli T, Maystruk G, Kurbanbekova D, Winikoff B. A prospective study of mifepristone and unlimited dosing of sublingual misoprostol for termination of second-trimester pregnancy in Uzbekistan and Ukraine. BMJ Sex Reprod Health. 2019 Jun 4:bmjsrh-2018-200167. doi: 10.1136/bmjsrh-2018-200167. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to examine the effectiveness and feasibility of a mifepristone-misoprostol medical abortion regimen in terminating pregnancies 13-22 weeks in Ukraine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with mid-trimester pregnancy seeking abortion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having an ongoing pregnancy of 13-22 weeks gestation\n* Be willing to undergo surgical completion if necessary\n* Have no contraindications to study procedures, according to provider\n* Be willing and able to consent to participate in the study\n* Be willing to follow study procedures\n\nExclusion Criteria:\n\n* Known allergy to mifepristone or misoprostol/prostaglandin\n* Any contraindications to vaginal delivery, including placenta previa\n* Unable to provide consent'}, 'identificationModule': {'nctId': 'NCT02415894', 'briefTitle': 'Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy in Ukraine', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Mifepristone and Misoprostol for Mid-trimester Termination of Pregnancy (13-22 Weeks LMP) in Ukraine', 'orgStudyIdInfo': {'id': '1025'}}, 'contactsLocationsModule': {'locations': [{'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Odessa Regional Hospital', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'city': 'Poltava', 'country': 'Ukraine', 'facility': 'Poltava City Maternity Hospital', 'geoPoint': {'lat': 49.58925, 'lon': 34.55367}}, {'city': 'Vinnitsa', 'country': 'Ukraine', 'facility': 'Vinnitsa Regional Hospital', 'geoPoint': {'lat': 49.84639, 'lon': 37.71861}}], 'overallOfficials': [{'name': 'Tamar Tsereteli, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Galina Maistruk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Woman Health and Family Planning Charitable Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}