Improving Access to Abortion in the Republic of Georgia

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy Related; Abortion Early
• Intervention / Treatment: Drug: Mifepristone

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nino Tsereteli, MA; Phone Number: +995 599 158 030; Email: tsereteli_nino@yahoo.com
• Study Contact Backup: Name: Lia Mamatsashvili, MD, MPH; Phone Number: +995 599 930 440; Email: l.mamatsashvili@gmail.com

Study Locations

• Georgia
  • Batumi, Georgia
    • Recruiting
    • Batumi Medical Center
    • Contact: Temur Gabaidze, MD; Phone Number: +995 577 442 328
  • Tbilisi, Georgia
    • Recruiting
    • David Gagua Clinic
    • Contact: George Tsertsvadze, MD; Phone Number: +995 599 553 047
  • Zestap'oni, Georgia
    • Recruiting
    • Clinic Elite
    • Contact: Kote Bochorishvili, MD; Phone Number: +995 599 516 227

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical abortion patients; Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone).	Drug: Mifepristone; Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Center for Information and Counseling on Reproductive Health - Tanadgoma
• Collaborators: Grand Challenges Canada; Gynuity Health Projects; Healthy Life

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: 2.1

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