Induced Abortion
Conditions
Keywords
mifepristone, misoprostol, medical abortion
Brief summary
This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.
Detailed description
The goal of this study is to provide answers to the following four questions: 1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)? 2. Are the side effects with buccal use tolerable for women? 3. Is buccal administration of misoprostol acceptable to women? 4. When given a choice, do women prefer to take misoprostol at home or in the clinic?
Interventions
200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
200mg mifepristone followed by 800mcg misoprostol 36-48 hours later
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women 18 years or over presenting for abortion services who consent to participate * good general health * assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion * Have ready access to a telephone and emergency transportation; * Be willing to provide an address and/or telephone number for purposes of follow-up
Exclusion criteria
* Conditions which contraindicate the use of mifepristone or misoprostol * Women presenting for medical abortion who do not consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22). | Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit |
Secondary
| Measure | Time frame |
|---|---|
| Side-effects, acceptability for women | side effects and acceptability recorded at exit interview |
Countries
Georgia, Vietnam
Outcome results
None listed