Improving Access to Abortion in the Republic of Georgia

Pregnancy Related Clinical Trial

Official title:

Improving Access to Abortion in the Republic of Georgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458558
• Other study ID #: 2.1
• Status: Recruiting
• Phase: Phase 4
• Start date: June 30, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: July 2020
• Source: Center for Information and Counseling on Reproductive Health - Tanadgoma
• Contact: Nino Tsereteli, MA
• Phone: +995 599 158 030
• Email: tsereteli_nino[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the Republic of Georgia, the medical abortion regimen involves three in-person visits. This study aims to pilot and evaluate a simplified medical abortion service delivery model that will reduce the number of in-person visits to only one visit for diagnosis and counseling. Medication will be mailed along with two multi-level pregnancy tests to study participants, who will assess their abortion outcome at home.

Description:

This prospective cohort study of patients obtaining medical abortion medications by mail. The study investigators aim to recruit approximately 120 patients for this study across three study sites that have extensive experience providing early medical abortion. Five days after undergoing in-person consultation and necessary exams to assess eligibility for medical abortion, study team will mail study participants medical abortion pills and two multi-level urine pregnancy tests. Medical abortion follow-up will occur at the participant's home approximately two weeks after the initial visit, and the multi-level pregnancy test will be used to assess abortion outcome. At follow-up, study participants will be asked questions about the results of the multi-level pregnancy test, and their experience and feedback about the acceptability of the process. At the conclusion of the study, investigators will interview providers to better undertand their experience with the simplified medical abortion service delivery model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Women seeking medical abortion through 58 days gestation

• Eligible for medical abortion according to study provider's assessment

• Able to receive physical mail

• Have access to a phone

• Be willing and able to consent to participate in the study

• Be willing to follow study procedures

Exclusion Criteria:

• Not seeking medical abortion

• Contraindications to medical abortion

Related Conditions & MeSH terms

• Abortion Early
• Pregnancy Related

Intervention

Drug:
• Mifepristone
Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.

Locations

Country	Name	City	State
Georgia	Batumi Medical Center	Batumi
Georgia	David Gagua Clinic	Tbilisi
Georgia	Clinic Elite	Zestap'oni

Sponsors (4)

Lead Sponsor	Collaborator
Center for Information and Counseling on Reproductive Health - Tanadgoma	Grand Challenges Canada, Gynuity Health Projects, Healthy Life

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who report satisfactory experience	Number of participants who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model	Day 14 following initial medical abortion visit
Primary	Number of providers who report satisfactory experience	Number of providers who report being "satisfied" or "very satisfied" with the simplified medical abortion service delivery model	End of the study, month 15
Secondary	Number of participants with adverse event	Number of participants who had a medical problem that required them to go to the hospital, emergency department or a doctor's office (other than regularly scheduled follow-up visit) since receiving medical abortion pills	Up to 6 weeks after initial medical abortion visit
Secondary	Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure	Number of participants who report that their abortion is complete as assessed by the multi-level pregnancy test and medical history.	Up to 6 weeks after initial medical abortion visit
Secondary	Number of particpants with adverse event associated with mailing of medical abortion medications	Number of participants who had a problem (such as delayed and lost packages) receiving medical abortion medications by mail	Up to 6 weeks after initial medical abortion visit
Secondary	Cost associated with the simplified medical abortion service delivery model	Cost savings associated with participant travel to the clinic and cost of the standard care at the clinic.	Up to 6 weeks after initial medical abortion visit
Secondary	Number of participants who refuse to receive medical abortion pills by mail	Number of participants who refuse to receive medical abortion pills by mail during the study period	End of the study, month 15