NCT00957346

Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)

Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP): A Randomized-controlled Double-blinded Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Conditions

• Abortion, Induced

Interventions

Type	Name	Description
DRUG	Mifepristone+misoprostol	single dose of 200 mg mifepristone followed 24 hours later by 400 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.
DRUG	Placebo+Misoprostol	placebo resembling mifepristone followed 24 hours later by 400 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2009-08-12
• Last updated: 2011-11-08

Locations

1 site across 1 country: Puerto Rico