Improving Access to Abortion in the Republic of Georgia

Center for Information and Counseling on Reproductive Health - Tanadgoma

Status and phase: Unknown; Phase 4

Conditions: Pregnancy Related; Abortion Early

Treatments: Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT04458558

2.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

Medical abortion patients

Experimental group

Description:

Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone).

Treatment:

Drug: Mifepristone