Clinical Trial: Same-day Cervical Preparation Before Dilation and Evacuation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestat

Brief Summary:

The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D&E at 16.0 to 20.0 weeks.

Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time.

Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D&E without further cervical preparation; ease of D&E; complications; pain; side effects; patient and provider satisfaction.

Detailed Summary:
Sponsor: Planned Parenthood of New York City, Inc.

Current Primary Outcome: Operative time [ Time Frame: From initiation of D&E procedure to completion of D&E procedure, Study Day 2 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Planned Parenthood of New York City, Inc.

Dates:
Date Received: December 6, 2016
Date Started: December 2016
Date Completion: July 2018
Last Updated: December 20, 2016
Last Verified: December 2016