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NCT05028387 Clinical Trial

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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05028387
Other study ID # 1053
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2021
Est. completion date February 2022

Study information
Verified date August 2021
Source Gynuity Health Projects
Contact Tamar Tsereteli, MD, PhD
Phone +995 599 501 229
Email ttsereteli@gynuity.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date February 2022
Est. primary completion date February 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• medical abortion
medical abortion

Locations
Country Name City State
Ukraine Clinic Vrachebnyye Traditsii Kiev
Uzbekistan Tashkent Medical Academy Clinic Tashkent

Sponsors (3)
Lead Sponsor Collaborator
Gynuity Health Projects Charitable Foundation Women Health and Family Planning, Ukraine, Womens Wellness Center, Uzbekistan

Countries where clinical trial is conducted

Ukraine,  Uzbekistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Satisfaction with remote provision of medical abortion Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. 6 weeks
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