Abortion, First Trimester
Conditions
Keywords
Mifepristone, Misoprostol, Buccal administration
Brief summary
This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen 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, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.
Interventions
DRUGmifepristone-misoprostol treatment
200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.
Sponsors
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Gestation up to 63 days * General good health * Willingness to provide contact information for follow-up * Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination
Exclusion criteria
* Ectopic pregnancy * Intrauterine device (IUD) in place
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| acceptability | 15 days |
Countries
Armenia, Azerbaijan, Mexico, Puerto Rico
Outcome results
None listed