NCT05459142

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

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

January 27, 2025

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 12, 2022

Last Update Submit

January 23, 2025

Conditions

Pregnancy Related

Keywords

TelemedicinePregnancy

Outcome Measures

Primary Outcomes (1)

  • The incidence rate of adverse events resulting from the 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

Participants who seek early first-trimester abortion at the participating study site and would like to receive telemedicine medical abortion services.

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 of 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 (1)

Scientific-Research Institute of Obstetrics and Gynecology

Baku, 1065, Azerbaijan

Location

Study Design

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

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 14, 2022

Study Start

June 1, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

January 27, 2025

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

AZ(1)