Improving Access to Abortion in the Republic of Georgia

NCT ID: NCT04458558

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abortion Early Pregnancy Related

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Cohort
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Medical abortion patients

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

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

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

Interventions

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Mifepristone

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role collaborator

Healthy Life

UNKNOWN

Sponsor Role collaborator

Grand Challenges Canada

OTHER

Sponsor Role collaborator

Center for Information and Counseling on Reproductive Health - Tanadgoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Batumi Medical Center

Batumi, , Georgia

Site Status RECRUITING

David Gagua Clinic

Tbilisi, , Georgia

Site Status RECRUITING

Clinic Elite

Zestaponi, , Georgia

Site Status RECRUITING

Countries

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Georgia

Central Contacts

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Nino Tsereteli, MA

Role: CONTACT

+995 599 158 030

Lia Mamatsashvili, MD, MPH

Role: CONTACT

+995 599 930 440

Facility Contacts

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Temur Gabaidze, MD

Role: primary

+995 577 442 328

George Tsertsvadze, MD

Role: primary

+995 599 553 047

Kote Bochorishvili, MD

Role: primary

+995 599 516 227

Other Identifiers

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2.1

Identifier Type: -

Identifier Source: org_study_id

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