NCT03002441

Same-day Cervical Preparation Before Dilation and Evacuation

Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestation: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Planned Parenthood of Greater New York · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Dilation Prior to Dilation and Evacuation

Interventions

Type	Name	Description
DEVICE	Same-Day Dilapan-S	Dilapan-S cervical dilators placed the same day as the D\&E procedure
DEVICE	Overnight Dilapan-S	Dilapan-S cervical dilators placed the day prior to D\&E procedure

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-01
• Completion: 2020-02-28
• First posted: 2016-12-23
• Last updated: 2021-04-22

Locations

1 site across 1 country: United States