TeleMAb Retrospective Cohort Study

February 5, 2026 updated by: Erika Levi, MD, Columbia University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032-3720
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Biologically female patients of reproductive age with an unwanted pregnancy seeking care at Columbia University's family planning clinics and interested in medication abortion.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Telemedicine Med Ab
Patients who received medication abortion through the telemedicine medication abortion service during the study period.
Other: Telemedicine Medication Abortion
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.
In-person Med Ab
Patients who received an in-person medication abortion at the clinic during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after initial encounter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Actual)

November 15, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • AAAV5073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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