Abortion, First Trimester
Conditions
Brief summary
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
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.
Interventions
Home administration of 200 mg mifepristone.
DRUGHome or clinic administration of 400 mcg buccal misoprostol
Home or clinic administration of 400 mcg buccal misoprostol
Sponsors
Gynuity Health Projects
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of abortions that are complete without surgical intervention (unit: percent) | 15 days | Percentage of women with complete abortion without the need of a surgical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent) | 15 days | Woman's satisfaction with her medical abortion procedure and side effects experienced. |
Other
| Measure | Time frame |
|---|---|
| Proportion of women who select home-use of mifepristone | 1 week |
| Proportion of women who select home-use of misoprostol | 1 week |
Countries
Georgia
Outcome results
None listed