Induced Abortion
Conditions
Keywords
Medical abortion, mifepristone, misoprostol
Brief summary
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally. The goal of this study is to provide answers to the following four questions: 1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)? 2. Are the side effects with sublingual use tolerable for women? 3. Is sublingual administration of misoprostol acceptable to women? 4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
Interventions
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women presenting for medical abortion who consent to participate * Possibility of final gestational age of less than or equal to 63 days * General good health * Willing to provide contact information 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 incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. | 2 weeks after mifepristone administration |
Secondary
| Measure | Time frame |
|---|---|
| Side effects | 48 hours |
| Acceptability for women | 2 weeks |
Countries
Moldova, Tunisia, Turkey (Türkiye)
Outcome results
None listed