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| Name | Class |
|---|---|
| Gynuity Health Projects | OTHER |
| Healthy Life | UNKNOWN |
| Grand Challenges Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical abortion patients | Experimental | Oral mifepristone 200 mg followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Batumi Medical Center | Recruiting | Batumi | Georgia |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Prospective Cohort
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| 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 |
| 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 |
| 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 |
| 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 |
| David Gagua Clinic | Recruiting | Tbilisi | Georgia |
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| Clinic Elite | Recruiting | Zestaponi | Georgia |
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| D011083 |
| Polycyclic Compounds |