Abortion Early, Pregnancy Related
Conditions
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.
Interventions
DRUGMifepristone
Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.
Sponsors
Gynuity Health Projects
Healthy Life
Grand Challenges Canada
Center for Information and Counseling on Reproductive Health - Tanadgoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Prospective Cohort
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who report satisfactory experience | Day 14 following initial medical abortion visit | Number of participants who report being satisfied or very satisfied with the simplified medical abortion service delivery model |
| Number of providers who report satisfactory experience | End of the study, month 15 | Number of providers who report being satisfied or very satisfied with the simplified medical abortion service delivery model |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of particpants with adverse event associated with mailing of medical abortion medications | Up to 6 weeks after initial medical abortion visit | Number of participants who had a problem (such as delayed and lost packages) receiving medical abortion medications by mail |
| Number of participants with adverse event | Up to 6 weeks after initial medical abortion visit | 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 |
| Number of participants who refuse to receive medical abortion pills by mail | End of the study, month 15 | Number of participants who refuse to receive medical abortion pills by mail during the study period |
| Cost associated with the simplified medical abortion service delivery model | Up to 6 weeks after initial medical abortion visit | Cost savings associated with participant travel to the clinic and cost of the standard care at the clinic. |
| Number of participants with a complete abortion with medication alone and who do not require additional interventions to complete the procedure | Up to 6 weeks after initial medical abortion visit | Number of participants who report that their abortion is complete as assessed by the multi-level pregnancy test and medical history. |
Countries
Georgia
Contacts
Primary ContactNino Tsereteli, MA
Backup ContactLia Mamatsashvili, MD, MPH
Outcome results
None listed