Pregnancy Clinical Trial
Official title:
Safety and Acceptability of a Telemedicine Medical Abortion Service Using the "No-test" Protocol In Ukraine and Uzbekistan.
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Ukraine | Clinic Vrachebnyye Traditsii | Kiev | |
Uzbekistan | Tashkent Medical Academy Clinic | Tashkent |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects | Charitable Foundation Women Health and Family Planning, Ukraine, Womens Wellness Center, Uzbekistan |
Ukraine, Uzbekistan,
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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