Same-day Cervical Preparation Before Dilation and Evacuation

Not Applicable

Completed

• Conditions: Cervical Dilation Prior to Dilation and Evacuation
• Interventions: Device: Same-Day Dilapan-S; Device: Overnight Dilapan-S

• Registration Number: NCT03002441
• Lead Sponsor: Planned Parenthood of Greater New York

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 Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Primary Completion: 2019-12
• Study Completion: 2020-02-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• 18 years of age and older
• Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of enrollment.
• Eligible for pregnancy termination at PPNYC
• Able to give informed consent
• English speaking

Exclusion Criteria

• Active bleeding or hemodynamically unstable at enrollment
• Signs of chorioamnionitis or clinical infection at enrollment
• Signs of spontaneous labor or cervical insufficiency at enrollment
• Spontaneous intrauterine fetal demise
• Allergy to Dilapan-S™ or misoprostol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Same-day Dilators	Same-Day Dilapan-S	Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D\&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D\&E.
Overnight dilators	Overnight Dilapan-S	Participants will have Dilapan-S cervical dilators placed the day prior to their D\&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D\&E.

Primary Outcome Measures

Name	Time	Method
Operative time	From initiation of D&E procedure to completion of D&E procedure, Study Day 2

Trial Locations

Locations (1)

Planned Parenthood of Greater New York; 🇺🇸 New York, New York, United States