Same-day Cervical Preparation Before Dilation and Evacuation

Completed · Not applicable

Conditions studied: Cervical Dilation Prior to Dilation and Evacuation

In brief

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.

Key facts

Study ID

NCT03002441

Run by

Planned Parenthood of Greater New York

People needed

54

Starts

2016-12-01

Expected to finish

2020-02-28

Last updated by the study team

2021-04-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Planned Parenthood of Greater New York — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.