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

NCT ID: NCT05028387

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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medical abortion

medical abortion

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charitable Foundation Women Health and Family Planning, Ukraine

UNKNOWN

Sponsor Role collaborator

Women's Wellness Center, Uzbekistan

UNKNOWN

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Clinic Vrachebnyye Traditsii

Kiev, , Ukraine

Site Status

Regional Clinical Hospital of Rehabilitation and Diagnostics of Poltava Regional Council

Poltava, , Ukraine

Site Status

Premium Medical Center, Bukhara Medical Institute

Bukhara, , Uzbekistan

Site Status

Tashkent Medical Academy Clinic

Tashkent, , Uzbekistan

Site Status

Countries

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Ukraine Uzbekistan

Other Identifiers

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1053

Identifier Type: -

Identifier Source: org_study_id

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