Medical Abortion
Conditions
Brief summary
This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.
Interventions
200 mg oral mifepristone 800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone
Sponsors
Gynuity Health Projects
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* intrauterine pregnancy of greater than 56 days and less than 71 days * eligible for medical abortion according to study doctor assessment * willing and able to sign consent forms * speak English or Spanish (in US sites); speak the local language(s) (in international sites) * agree to comply with the study procedures and visit schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion | 7-36 days |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of individual side effects experienced by participants | 7-14 days |
| Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain) | 7-14 days |
| Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began | 7-14 days |
| Average number of missed days of work or school due to the abortion procedure | 7-14 days |
Countries
Georgia, India, Tunisia, Ukraine, United States
Outcome results
None listed