NCT00969982

Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• 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 120 women in each country 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 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
DRUG	misoprostol+placebo	placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2009-09-02
• Last updated: 2014-02-20

Locations

2 sites across 2 countries: Moldova, Tunisia