NCT01436279

Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

Conditions

• Cervical Preparation

Interventions

Type	Name	Description
DRUG	Mifepristone	200 mg po 20-24 hours prior to the procedure
DEVICE	osmotic dilators	osmotic dilators placed in the cervix 20-24 hours prior to the procedure

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-09-19
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study