Trials / Unknown
UnknownNCT04458558
Improving Access to Abortion in the Republic of Georgia
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Center for Information and Counseling on Reproductive Health - Tanadgoma · Academic / Other
- Sex
- Female
- Age
- 16 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mifepristone | Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit. |
Timeline
- Start date
- 2020-06-30
- Primary completion
- 2021-04-01
- Completion
- 2021-04-01
- First posted
- 2020-07-07
- Last updated
- 2020-07-07
Locations
3 sites across 1 country: Georgia
Source: ClinicalTrials.gov record NCT04458558. Inclusion in this directory is not an endorsement.