ClinicalTrials.gg
CompletedNCT05028387Updated Jan 27, 2025

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

An observational study in Pregnancy, sponsored by Gynuity Health Projects. Completed at 4 sites in 2 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Gynuity Health Projects · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Pregnancy
03

In context

Lead sponsor

Gynuity Health Projects is the lead sponsor of 113 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

People seeking abortion

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Is pregnant as determined by a pregnancy test or ultrasound (if obtained prior to contacting the study site)
  • Has no to medical abortion
  • Has access to a phone
  • Is able to take mifepristone on or before 63 days gestation

Exclusion criteria

Exclusion Criteria:

  • Medically ineligible for medical abortion
  • Gestational age above 63 days based on LMP
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No

Interventions

  • Drugmedical abortion

    medical abortion

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 weeks

Secondary outcomes

  1. Satisfaction with remote provision of medical abortion

    Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. We will be using 1-5 score, 1. very satisfied, 2. satisfied 3. neutral 4. unsatisfied 5. very unsatisfied, Higher scores mean worse outcome.

    Time frame: 6 weeks

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Study locations

4 sites
  • Clinic Vrachebnyye Traditsii
    Kiev, Ukraine
  • Regional Clinical Hospital of Rehabilitation and Diagnostics of Poltava Regional Council
    Poltava, Ukraine
  • Premium Medical Center, Bukhara Medical Institute
    Bukhara, Uzbekistan
  • Tashkent Medical Academy Clinic
    Tashkent, Uzbekistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05028387
Collaborators
Charitable Foundation Women Health and Family Planning, Ukraine, Women's Wellness Center, Uzbekistan
Responsible party
Sponsor
First posted
Aug 31, 2021
Start date
Sep 1, 2021
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Jan 27, 2025

Study contacts

Beverly Winikoff, MD, MPH
principal investigator · Gynuity Health Projects

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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