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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459142
• Other study ID #: 1057
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2022
• Source: Gynuity Health Projects
• Contact: Tamar Tsereteli, MD,PHD
• Phone: +995 599 501 229
• Email: ttsereteli[@]gynuity.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Drug:
• Medical Abortion
Medical Abortion

Locations

Country	Name	City	State
Azerbaijan	Scientific-Research Institute of Obstetrics and Gynecology	Baku

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Scientific Research Institute of Obstetrics and Gynecology

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Satisfaction with remote provision of medical abortion	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