NCT01768299

Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 504 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.

Conditions

• Complete Uterine Evacuation After Use of Study Drugs

Interventions

Type	Name	Description
DRUG	Mifepristone	200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
DRUG	Misoprostol	200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-01-15
• Last updated: 2014-05-14

Locations

3 sites across 1 country: Vietnam