Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan.

July 12, 2022 updated by: Gynuity Health Projects

Safety and Acceptability of Telemedicine Medical Abortion Service Using the "No-test" Protocol in Azerbaijan.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Azerbaijan
      • Baku, Azerbaijan, 1065
        • Recruiting
        • Scientific-Research Institute of Obstetrics and Gynecology
        • Contact:
        • Contact:
          • Djamila Kurbanova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

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 of gestation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of adverse events resulting from the 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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with remote provision of medical abortion
Time Frame: 6-weeks
Satisfaction with remote provision of medical abortion measures by 5-point Likert scale. We will be using a 1-5 score system. 1 being very satisfied and 5 being very unsatisfied. A higher score means a worse outcome.
6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Collaborators

Scientific Research Institute of Obstetrics and Gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2022

Primary Completion (ANTICIPATED)

November 30, 2022

Study Completion (ANTICIPATED)

November 30, 2022

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (ACTUAL)

July 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1057 (Other Identifier: National Health Sciences Research Committee (NHSRC) Malawi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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