NCT00855842

Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Boston University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)

Detailed description

This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.

Conditions

• Abortion, Induced

Interventions

Type	Name	Description
DEVICE	osmotic dilator insertion	osmotic dilators are placed in the cervix to cause cervical dilation

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-03-04
• Last updated: 2011-07-08
• Results posted: 2011-07-08

Locations

1 site across 1 country: United States