Cervical Dilation Prior to Dilation and Evacuation
Conditions
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.
Interventions
DEVICESame-Day Dilapan-S
Dilapan-S cervical dilators placed the same day as the D&E procedure
DEVICEOvernight Dilapan-S
Dilapan-S cervical dilators placed the day prior to D&E procedure
Sponsors
Planned Parenthood of Greater New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operative time | From initiation of D&E procedure to completion of D&E procedure, Study Day 2 |
Countries
United States
Outcome results
None listed