NCT05028387

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 27, 2025

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

August 25, 2021

Last Update Submit

January 23, 2025

Conditions

Pregnancy

Outcome Measures

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.

    6 weeks

Secondary Outcomes (1)

  • Satisfaction with remote provision of medical abortion

    6 weeks

Interventions

medical abortionDRUG

medical abortion

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People seeking abortion

You may qualify if:

  • 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

You may not qualify if:

  • Medically ineligible for medical abortion
  • Gestational age above 63 days based on LMP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinic Vrachebnyye Traditsii

Kiev, Ukraine

Location

Regional Clinical Hospital of Rehabilitation and Diagnostics of Poltava Regional Council

Poltava, Ukraine

Location

Premium Medical Center, Bukhara Medical Institute

Bukhara, Uzbekistan

Location

Tashkent Medical Academy Clinic

Tashkent, Uzbekistan

Location

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 31, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 27, 2025

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

UA(2)UZ(2)