CompletedNot Applicable

Same-day Cervical Preparation Before Dilation and Evacuation

United States54 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Operative time

Timeframe: From initiation of D&E procedure to completion of D&E procedure, Study Day 2

Trial details

NCT IDNCT03002441

SponsorPlanned Parenthood of Greater New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Cervical Dilation Prior to Dilation and Evacuation trials