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

Not Applicable

Terminated

• Conditions: Abortion, Induced
• Interventions: Device: osmotic dilator insertion

• Registration Number: NCT00855842
• Lead Sponsor: Boston University

Brief 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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-04-04
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-10
• Last Update Submitted: 2011-06-10
• Results First Posted: 2011-07-08
• Last Update Posted: 2011-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• Requesting abortion 19-23 weeks
• No contraindication to induction abortion

Exclusion Criteria

• Fetal demise
• Ruptured membranes
• Evidence of pelvic infection
• Inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
osmotic dilator	osmotic dilator insertion	osmotic dilator

Primary Outcome Measures

Name	Time	Method
Length of Medical Abortion	hours since the start of medical abortion	This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States