Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus

Study Overview
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Brief Summary
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This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.

Official Title
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Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus

Conditions
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Abortion, First Trimester

Intervention / Treatment
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* Drug: Home administration of 200 mg mifepristone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Good general health Living or working close to the study site Intrauterine pregnancy less than 64 days gestation Willing and able to sign consent forms Eligible for medical abortion according to the clinician's assessment Ready access to a telephone and emergency transportation Willing to provide an address and/or telephone number for purposes of follow-up Agree to comply with the study procedures and visit schedule Exclusion Criteria: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass IUD in place (IUD must be removed first) Chronic renal failure Concurrent long-term corticosteroid therapy History of allergy to mifepristone, misoprostol or other prostaglandin Hemorrhagic disorders or concurrent anticoagulant therapy Inherited porphyrias Other serious physical or mental health conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home administration of mifepristone<br>This arm consisted of women who chose home administration of 200 mg mifepristone. | Drug: Home administration of 200 mg mifepristone<br>* Home administration of 200 mg mifepristone<br>|
| No Intervention: Clinic administration of mifepristone<br>This arm consisted of women who underwent clinic administration of 200 mg mifepristone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of abortions that are complete without surgical intervention (unit: percent). | Percentage of women with complete abortion without the need of a surgical intervention. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent). | Woman's satisfaction with her medical abortion procedure and side effects experienced. | 15 days |