Pregnancy Related Clinical Trial
Official title:
Improving Access to Abortion in the Republic of Georgia
NCT number | NCT04458558 |
Other study ID # | 2.1 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 30, 2020 |
Est. completion date | April 1, 2021 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Georgia | Batumi Medical Center | Batumi | |
Georgia | David Gagua Clinic | Tbilisi | |
Georgia | Clinic Elite | Zestap'oni |
Lead Sponsor | Collaborator |
---|---|
Center for Information and Counseling on Reproductive Health - Tanadgoma | Grand Challenges Canada, Gynuity Health Projects, Healthy Life |
Georgia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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