Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.

Safety and Acceptability of a Telemedicine Medical Abortion Service Using the "No-test" Protocol In Ukraine and Uzbekistan.

The goal of this study is to pilot and evaluate a telemedicine medical abortion service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Drug: medical abortion

Detailed Description

The goal of this study is to pilot and evaluate a telemedicine medical abortion (TMA) service delivery that allows remote communication between the woman and provider and limits medically unnecessary in-person visits to health or diagnostic centers. Providers will provide counseling by phone or video about pregnancy options and give detailed information about the medical abortion process, expected side effects, and where to seek additional care. The provider will then evaluate the woman's eligibility for TMA service by following the no-test protocol and discuss at-home follow-up using a symptom checklist and a high-sensitivity urine pregnancy test. If pre-treatment tests are needed, women will be referred to a nearby diagnostic center and test results will be forwarded to the study provider. Participants will receive medications by mail or courier service or pick them up at the pharmacy or study clinics, take medications as instructed, and complete at-home follow-ups as discussed with the provider.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Ukraine
  • Kiev, Ukraine
    • Clinic Vrachebnyye Traditsii
  • Poltava, Ukraine
    • Regional Clinical Hospital of Rehabilitation and Diagnostics of Poltava Regional Council
• Uzbekistan
  • Bukhara, Uzbekistan
    • Premium Medical Center, Bukhara Medical Institute
  • Tashkent, Uzbekistan
    • Tashkent Medical Academy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People seeking abortion

Description

Inclusion Criteria:

• Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site)
• Has no contraindications to medical abortion
• Has access to a phone
• Is able to take mifepristone on or before 63 days gestation

Exclusion Criteria:

• Medically ineligible for medical abortion
• Gestational age above 63 days based on LMP

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of adverse events resulting from remote provision of medical abortion	Adverse events such as regimen non-compliance or medically unnecessary interventions associated with remote provision of medical abortion.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with remote provision of medical abortion	Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. We will be using 1-5 score,; very satisfied,; satisfied; neutral; unsatisfied; very unsatisfied, Higher scores mean worse outcome.	6 weeks

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Charitable Foundation Women Health and Family Planning, Ukraine; Women's Wellness Center, Uzbekistan
• Investigators: Principal Investigator: Beverly Winikoff, MD, MPH, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1053

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