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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home administration of mifepristone | Experimental | Home administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. |
|
| Clinic administration of mifepristone | Active Comparator | Clinic administration of 200 mg mifepristone. Choice of home or clinic administration of 400 mcg buccal misoprostol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home administration of 200 mg mifepristone | Drug | Home administration of 200 mg mifepristone. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women who select home-use of mifepristone | 1 week | |
| Proportion of women who select home-use of misoprostol | 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Batumi Maternity House | Batumi | Adjara | Georgia | |||
| Zestafoni Maternity House |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D006699 | Home Care Services |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Home or clinic administration of 400 mcg buccal misoprostol | Drug | Home or clinic administration of 400 mcg buccal misoprostol |
|
| Zestaponi |
| Imereti |
| Georgia |
| A. Kambarashvili Clinic | Telavi | Kakheti | Georgia |
| Bolnisi Maternity House | Bolnisi | Kvemo Kartli | Georgia |
| D011083 |
| Polycyclic Compounds |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D009739 | Nursing Services |