Induced Abortion
Conditions
Keywords
Medical abortion, mifepristone, misoprostol, Tunisia
Brief summary
This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions. The goal of this study is to provide answers to the following four questions: 1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual 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. Are women satisfied with counseling and services received in new centers offering medical abortion?
Interventions
Sponsors
Centre de Formation et de la Recherche, Tunisia
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
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
Tunisia
Outcome results
None listed