Same-day Cervical Preparation Before Dilation and Evacuation

Cervical Dilation Prior to Dilation and Evacuation Clinical Trial

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' Gestation: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002441
• Other study ID #: Same Day CPrep
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2021
• Source: Planned Parenthood of Greater New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 28, 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dilation Prior to Dilation and Evacuation

Intervention

Device:
• Same-Day Dilapan-S
Dilapan-S cervical dilators placed the same day as the D&E procedure
• Overnight Dilapan-S
Dilapan-S cervical dilators placed the day prior to D&E procedure

Locations

Country	Name	City	State
United States	Planned Parenthood of Greater New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Planned Parenthood of Greater New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time		From initiation of D&E procedure to completion of D&E procedure, Study Day 2