Improving Access to Abortion in the Republic of Georgia

NCT04458558 | Unknown Phase 4

• 1 other identifier: 2.1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Abortion Early; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Number of participants with adverse event

  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

  Up to 6 weeks after initial medical abortion visit

• Number of particpants with adverse event associated with mailing of medical abortion medications

  Up to 6 weeks after initial medical abortion visit

• Cost associated with the simplified medical abortion service delivery model

  Up to 6 weeks after initial medical abortion visit

• Number of participants who refuse to receive medical abortion pills by mail

  End of the study, month 15

Study Arms (1)

Medical abortion patients

EXPERIMENTAL

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

Drug: Mifepristone

Interventions

Mifepristone DRUG

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

Medical abortion patients

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not seeking medical abortion
• Contraindications to medical abortion

Sponsors & Collaborators

• Center for Information and Counseling on Reproductive Health - Tanadgoma: lead
• Gynuity Health Projects: collaborator
• Healthy Life: collaborator
• Grand Challenges Canada: collaborator

Study Sites (3)

Batumi Medical Center

Batumi, Georgia

RECRUITING

David Gagua Clinic

Tbilisi, Georgia

RECRUITING

Clinic Elite

Zestaponi, Georgia

RECRUITING

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Nino Tsereteli, MA

CONTACT

+995 599 158 030; tsereteli_nino@yahoo.com

Lia Mamatsashvili, MD, MPH

CONTACT

+995 599 930 440; l.mamatsashvili@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Cohort

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: June 30, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GE (3)