Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04458558
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2020-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Access to Abortion in the Republic of Georgia
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective Cohort'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who report satisfactory experience', 'timeFrame': 'Day 14 following initial medical abortion visit', 'description': 'Number of participants who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model'}, {'measure': 'Number of providers who report satisfactory experience', 'timeFrame': 'End of the study, month 15', 'description': 'Number of providers who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse event', 'timeFrame': 'Up to 6 weeks after initial medical abortion visit', 'description': "Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving medical abortion pills"}, {'measure': 'Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure', 'timeFrame': 'Up to 6 weeks after initial medical abortion visit', 'description': 'Number of participants who report that their abortion is complete as assessed by the multi-level pregnancy test and medical history.'}, {'measure': 'Number of particpants with adverse event associated with mailing of medical abortion medications', 'timeFrame': 'Up to 6 weeks after initial medical abortion visit', 'description': 'Number of participants who had a problem (such as delayed and lost packages) receiving medical abortion medications by mail'}, {'measure': 'Cost associated with the simplified medical abortion service delivery model', 'timeFrame': 'Up to 6 weeks after initial medical abortion visit', 'description': 'Cost savings associated with participant travel to the clinic and cost of the standard care at the clinic.'}, {'measure': 'Number of participants who refuse to receive medical abortion pills by mail', 'timeFrame': 'End of the study, month 15', 'description': 'Number of participants who refuse to receive medical abortion pills by mail during the study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abortion Early', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. Medication will be mailed along with two multi-level pregnancy tests to study participants, who will assess their abortion outcome at home.', 'detailedDescription': "This prospective cohort study of patients obtaining medical abortion medications by mail. The study investigators aim to recruit approximately 120 patients for this study across three study sites that have extensive experience providing early medical abortion. Five days after undergoing in-person consultation and necessary exams to assess eligibility for medical abortion, study team will mail study participants medical abortion pills and two multi-level urine pregnancy tests. Medical abortion follow-up will occur at the participant's home approximately two weeks after the initial visit, and the multi-level pregnancy test will be used to assess abortion outcome. At follow-up, study participants will be asked questions about the results of the multi-level pregnancy test, and their experience and feedback about the acceptability of the process. At the conclusion of the study, investigators will interview providers to better undertand their experience with the simplified medical abortion service delivery model."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women seeking medical abortion through 58 days gestation\n* Eligible for medical abortion according to study provider's assessment\n* Able to receive physical mail\n* Have access to a phone\n* Be willing and able to consent to participate in the study\n* Be willing to follow study procedures\n\nExclusion Criteria:\n\n* Not seeking medical abortion\n* Contraindications to medical abortion"}, 'identificationModule': {'nctId': 'NCT04458558', 'briefTitle': 'Improving Access to Abortion in the Republic of Georgia', 'organization': {'class': 'OTHER', 'fullName': 'Center for Information and Counseling on Reproductive Health - Tanadgoma'}, 'officialTitle': 'Improving Access to Abortion in the Republic of Georgia', 'orgStudyIdInfo': {'id': '2.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical abortion patients', 'description': 'Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone).', 'interventionNames': ['Drug: Mifepristone']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.', 'armGroupLabels': ['Medical abortion patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Batumi', 'status': 'RECRUITING', 'country': 'Georgia', 'contacts': [{'name': 'Temur Gabaidze, MD', 'role': 'CONTACT', 'phone': '+995 577 442 328'}], 'facility': 'Batumi Medical Center', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'contacts': [{'name': 'George Tsertsvadze, MD', 'role': 'CONTACT', 'phone': '+995 599 553 047'}], 'facility': 'David Gagua Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Zestaponi', 'status': 'RECRUITING', 'country': 'Georgia', 'contacts': [{'name': 'Kote Bochorishvili, MD', 'role': 'CONTACT', 'phone': '+995 599 516 227'}], 'facility': 'Clinic Elite', 'geoPoint': {'lat': 42.10752, 'lon': 43.03291}}], 'centralContacts': [{'name': 'Nino Tsereteli, MA', 'role': 'CONTACT', 'email': 'tsereteli_nino@yahoo.com', 'phone': '+995 599 158 030'}, {'name': 'Lia Mamatsashvili, MD, MPH', 'role': 'CONTACT', 'email': 'l.mamatsashvili@gmail.com', 'phone': '+995 599 930 440'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Information and Counseling on Reproductive Health - Tanadgoma', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gynuity Health Projects', 'class': 'OTHER'}, {'name': 'Healthy Life', 'class': 'UNKNOWN'}, {'name': 'Grand Challenges Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}