Safety and Acceptability of a Telemedicine Medical Abortion Service Using the "No-test" Protocol In Ukraine and Uzbekistan.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- Gynuity Health Projects
- Enrollment
- 250
- Locations
- 4
- Primary Endpoint
- Incidence rate of adverse events resulting from remote provision of medical abortion
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence rate of adverse events resulting from remote provision of medical abortion
Time Frame: 6 weeks
Adverse events such as regimen non-compliance or medically unnecessary interventions associated with remote provision of medical abortion.
Secondary Outcomes
- Satisfaction with remote provision of medical abortion(6 weeks)