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

Completed

• Conditions: Pregnancy

• Registration Number: NCT05028387
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Study Start: 2021-09-01
• Status Verified: 2022-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Satisfaction with remote provision of medical abortion	6 weeks	Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. We will be using 1-5 score,; 1. very satisfied,; 2. satisfied; 3. neutral; 4. unsatisfied; 5. very unsatisfied,; Higher scores mean worse outcome.

Trial Locations

Locations (4)

Regional Clinical Hospital of Rehabilitation and Diagnostics of Poltava Regional Council; 🇺🇦 Poltava, Ukraine

Premium Medical Center, Bukhara Medical Institute; 🇺🇿 Bukhara, Uzbekistan

Clinic Vrachebnyye Traditsii; 🇺🇦 Kiev, Ukraine

Tashkent Medical Academy Clinic; 🇺🇿 Tashkent, Uzbekistan