Clinical trial NCT05028387: Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Official title: Safety and Acceptability of a Telemedicine Medical Abortion Service Using the "No-test" Protocol In Ukraine and Uzbekistan.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Charitable Foundation Women Health and Family Planning, Ukraine
name: Women's Wellness Center, Uzbekistan
First posted: 2021-08-31
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People seeking abortion

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.

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

Primary outcomes:
measure: Incidence rate of adverse events resulting from remote provision of medical abortion
timeFrame: 6 weeks
Secondary outcomes:
measure: Satisfaction with remote provision of medical abortion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: Clinic Vrachebnyye Traditsii
city: Poltava
country: Ukraine
facility: Regional Clinical Hospital of Rehabilitation and Diagnostics of Poltava Regional Council
city: Bukhara
country: Uzbekistan
facility: Premium Medical Center, Bukhara Medical Institute
city: Tashkent
country: Uzbekistan
facility: Tashkent Medical Academy Clinic
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: