Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia

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 the eastern and western regions of the country of Georgia. It was hypothesized that home use of mifepristone and buccal administration of misoprostol would be both acceptable and efficacious.

Detailed Description
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The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking mifepristone to determine if their medical abortions were complete. The study assessed the regimen's efficacy, women's preferences regarding where to administer the medications, and the acceptability of buccal misoprostol and of side effects that accompanied women's medical abortions.

Official Title
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Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia: A Study of 400 mcg Buccal Misoprostol Following 200 mg Mifepristone for Abortion up to 63 Days Gestation

Conditions
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Abortion, First Trimester

Intervention / Treatment
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* Drug: Home administration of 200 mg mifepristone
* Drug: Home or clinic administration of 400 mcg buccal misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old In 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 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>Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. | Drug: Home administration of 200 mg mifepristone<br>* Home administration of 200 mg mifepristone.<br>* Other names: Penkrofton;Drug: Home or clinic administration of 400 mcg buccal misoprostol<br>* Home or clinic administration of 400 mcg buccal misoprostol<br>|
| Active Comparator: Clinic administration of mifepristone<br>Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. | Drug: Home or clinic administration of 400 mcg buccal misoprostol<br>* Home or clinic administration of 400 mcg buccal misoprostol<br>|

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 |