NCT02018796

Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days' Gestation in Kazakhstan

Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Kazakhstan: A Study of 600 µg Sublingual Misoprostol Following 200 mg Mifepristone for Abortion up to 70 Days Gestation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 290 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The study will be conducted in 4 sites and will examine how a simplified outpatient medical abortion procedure using mifepristone and misoprostol, with the option to take mifepristone at a place of woman's choosing, works in Kazakhstan. The investigators intend to demonstrate the efficacy of oral administration of 200 mg mifepristone and sublingual administration of 600 µg misoprostol with gestations through 70 days, as well as the acceptability of this method. Research questions include: 1. What is the efficacy of regimen of 200 mg mifepristone, followed 24 to 48 hours later by 600 µg sublingual misoprostol and used in gestations of up to 70 days? 2. Is medical abortion procedure consisting of two visits acceptable to women in Kazakhstan? 3. Are the side effects associated with sublingual use of misoprostol acceptable to women? 4. When given a choice, do women prefer to take mifepristone in the clinic or at a place of their choosing?

Conditions

• Complete Abortion

Interventions

Type	Name	Description
DRUG	Mifepristone, misoprostol	200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-12-23
• Last updated: 2015-08-13

Locations

4 sites across 1 country: Kazakhstan