Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
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:
- 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)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation|
- Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
- Side effects
- Acceptability for women
|Study Start Date:||August 2005|
|Study Completion Date:||January 2008|
|Moldova, Republic of|
|State University of Medicine and Pharmacy|
|Chisinau, Moldova, Republic of|
|Centre de Planification Familiale de l'Ariana|
|Centre de Planification Familiale la Bardo|
|Maternité de La Rabta|
|MoH Ankara Etlik Maternity and Gyneacological Training Hospital|
|Dr. Zekai Tahir Burak Women's Health Training and Research Hospital|
|Haydarpaşa Numune Training and Research Hospital Family Planning Clinic|
|Ege Maternity and Gyneacological Training and Research Hospital|
|Study Director:||Sheila Raghavan, M.Sc.||Gynuity Health Projects|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|
|Study Director:||Rasha Dabash, MPH||Gynuity Health Projects|
|Principal Investigator:||Selma Hajri, MD||Reproductive Health Consultant|
|Principal Investigator:||Ayse Akin, MD, MPH||Baskent University|
|Study Director:||Ilana Dzuba, MHS||Gynuity Health Projects|