Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:29 AM
Study NCT ID:
NCT07405294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TeleMAb Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of unscheduled follow-ups', 'timeFrame': '3 months after initial encounter', 'description': 'If patients engaged in follow-up are outside of their routinely scheduled follow-up visit 1-2 weeks after medication abortion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medication Abortion', 'Telemedicine']}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate whether there are different clinical outcomes and unscheduled follow-ups between in-person and telemedicine medication abortion, and to better understand patients' experiences with telemedicine medication abortion and their motivations for seeking unscheduled follow-up care in a setting where abortion care, including both virtual and in-person follow-up care, is readily accessible.", 'detailedDescription': 'This study will be retrospective chart review comparing clinical and demographic characteristics, eligibility, treatment success, participation in unscheduled and scheduled follow-ups, and adverse events of patients who obtained a telemedicine medication abortion through the Telehealth Medication Abortion Clinic with patients who received an in-person medication abortion provided at the Family Planning Faculty Practice from June 2023 through September 2024.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Biologically female patients of reproductive age with an unwanted pregnancy seeking care at Columbia University's family planning clinics and interested in medication abortion.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Received telemedicine or in-person medication abortion at Columbia University Irving Medical Center's associated practices from June 12, 2023 through September 30, 2024\n* Gestational age \\<70 days (based on best obstetrical dating)\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Received mifepristone and misoprostol for early pregnancy loss\n* Patient determined to have contraindication to medication abortion\n* Opted for procedural management instead of medication abortion\n* Decided to continue with the pregnancy\n* Presenting for a second medication abortion at CUIMC during the study period\n* Non-English or Spanish speaking"}, 'identificationModule': {'nctId': 'NCT07405294', 'briefTitle': 'TeleMAb Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'A Retrospective Cohort Study Comparing Clinical Outcomes and Unscheduled Follow-up of Telemedicine and In-person Medication Abortion', 'orgStudyIdInfo': {'id': 'AAAV5073'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Telemedicine Med Ab', 'description': 'Patients who received medication abortion through the telemedicine medication abortion service during the study period.', 'interventionNames': ['Other: Telemedicine Medication Abortion']}, {'label': 'In-person Med Ab', 'description': 'Patients who received an in-person medication abortion at the clinic during the study period.'}], 'interventions': [{'name': 'Telemedicine Medication Abortion', 'type': 'OTHER', 'description': 'Meeting with a clinician via video visit to determine if patient is eligible for medication abortion without pre-treatment ultrasound or laboratory testing. If eligible, the patient travels to clinic to pick up medications in person.', 'armGroupLabels': ['Telemedicine Med Ab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032-3720', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Wyeth-Ayerst Associate Professor of Women's Health in Obstetrics and Gynecology", 'investigatorFullName': 'Erika Levi, MD', 'investigatorAffiliation': 'Columbia University'}}}}