Same-day Cervical Preparation Before Dilation and Evacuation
- Conditions
- Cervical Dilation Prior to Dilation and Evacuation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 54
- 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
- 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
- Primary Outcome Measures
Name Time Method Operative time From initiation of D&E procedure to completion of D&E procedure, Study Day 2
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Planned Parenthood of Greater New York
🇺🇸New York, New York, United States
Planned Parenthood of Greater New York🇺🇸New York, New York, United States