Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia
- Conditions
- Induced Abortion
- Registration Number
- NCT01173003
- Lead Sponsor
- Gynuity Health Projects
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 688
- 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
- Conditions which contraindicate the use of mifepristone or misoprostol
- Women presenting for medical abortion who do not consent to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. 2 weeks after mifepristone administration
- Secondary Outcome Measures
Name Time Method Side effects 48 hours Acceptability for women 2 weeks
Trial Locations
- Locations (1)
Centres (14) de Planification Familiale de L'ONFP
🇹🇳Tunis, Various, Tunisia