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Clinical Trials/NCT07405294
NCT07405294
Active, not recruiting
Not Applicable

A Retrospective Cohort Study Comparing Clinical Outcomes and Unscheduled Follow-up of Telemedicine and In-person Medication Abortion

Columbia University1 site in 1 country400 target enrollmentStarted: June 12, 2023Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
400
Locations
1
Primary Endpoint
Number of unscheduled follow-ups

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Received telemedicine or in-person medication abortion at Columbia University Irving Medical Center's associated practices from June 12, 2023 through September 30, 2024
  • Gestational age \<70 days (based on best obstetrical dating)
  • English or Spanish speaking

Exclusion Criteria

  • Received mifepristone and misoprostol for early pregnancy loss
  • Patient determined to have contraindication to medication abortion
  • Opted for procedural management instead of medication abortion
  • Decided to continue with the pregnancy
  • Presenting for a second medication abortion at CUIMC during the study period
  • Non-English or Spanish speaking

Arms & Interventions

Telemedicine Med Ab

Patients who received medication abortion through the telemedicine medication abortion service during the study period.

Intervention: Telemedicine Medication Abortion (Other)

In-person Med Ab

Patients who received an in-person medication abortion at the clinic during the study period.

Outcomes

Primary Outcomes

Number of unscheduled follow-ups

Time Frame: 3 months after initial encounter

If patients engaged in follow-up are outside of their routinely scheduled follow-up visit 1-2 weeks after medication abortion

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Erika Levi, MD

Wyeth-Ayerst Associate Professor of Women's Health in Obstetrics and Gynecology

Columbia University

Study Sites (1)

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