Clinical trial NCT04458558: Improving Access to Abortion in the Republic of Georgia
Official title: Improving Access to Abortion in the Republic of Georgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abortion Early
Pregnancy Related
Lead sponsor: Center for Information and Counseling on Reproductive Health - Tanadgoma
Sponsor class: OTHER
Collaborators: name: Gynuity Health Projects
name: Healthy Life
name: Grand Challenges Canada
First posted: 2020-07-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who report satisfactory experience
timeFrame: Day 14 following initial medical abortion visit
measure: Number of providers who report satisfactory experience
timeFrame: End of the study, month 15
Secondary outcomes:
measure: Number of participants with adverse event
timeFrame: Up to 6 weeks after initial medical abortion visit
measure: Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure
timeFrame: Up to 6 weeks after initial medical abortion visit
measure: Number of particpants with adverse event associated with mailing of medical abortion medications
timeFrame: Up to 6 weeks after initial medical abortion visit
measure: Cost associated with the simplified medical abortion service delivery model
timeFrame: Up to 6 weeks after initial medical abortion visit
measure: Number of participants who refuse to receive medical abortion pills by mail
timeFrame: End of the study, month 15
Other outcomes:
Locations:
city: Batumi
country: Georgia
facility: Batumi Medical Center
city: Tbilisi
country: Georgia
facility: David Gagua Clinic
city: Zestap'oni
country: Georgia
facility: Clinic Elite
Study officials:
References: