Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Not Applicable

Completed

• Conditions: Abortion
• Interventions: Drug: mifepristone 200 mg; Device: osmotic dilator insertion

• Registration Number: NCT00986921
• Lead Sponsor: Boston University

Brief Summary

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-28
• Study First Posted: 2009-09-30
• Study Start: 2009-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-09-07
• Results First Submitted QC: 2013-09-29
• Status Verified: 2013-12
• Results First Posted: 2013-12-02
• Last Update Submitted: 2013-12-28
• Last Update Posted: 2014-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion Criteria

• multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mifepristone	mifepristone 200 mg	women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed.
Osmotic dilator insertion	osmotic dilator insertion	Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure

Primary Outcome Measures

Name	Time	Method
Time for Completion of Procedure	Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.	Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)

Secondary Outcome Measures

Name	Time	Method
Assessment of Ease of Procedure by Operator	It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.	The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult".
Moderate or Severe Pain Overnight	Overnight	Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)

Trial Locations

Locations (1)

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