This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time. Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
A single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own.
Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
Boston Medical Center
Boston, Massachusetts, United States
RECRUITINGDilation & Evacuation (D&E) Operative time
the total duration in D\&E operative time measured in minutes. Operative start time will be marked as the time that the speculum is inserted for the first time. Operative end time will be marked as the time that the speculum is removed at the end of the case.
Time frame: at end of procedure about 20 minutes
Participant preoperative pain
Participant pain will be assessed via a 100 point visual analog scale immediately post-cervical preparation and at every hour interval until their D\&E. Higher scores are associated with more pain.
Time frame: every hour until procedure, on average 3 hours
Participant satisfaction
Participant satisfaction will be assessed with a 5-point Likert scale from very dissatisfied to very satisfied.
Time frame: after dilation, on average 3 hours
Cervical dilation
Cervical dilation will be measured in millimeters at the beginning of the procedure by the surgeon.
Time frame: beginning of procedure, on average 3 hours
Number of participants with adequate cervical dilation
Abstracted from the operative record, dilation will be considered adequate if no manual dilation is needed.
Time frame: beginning of procedure, on average 3 hours
Number of participants with surgery completed in the same day
Abstracted from the electronic medical record, whether the surgery was completed in the same day as the dilation will be recorded as yes or no.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.