The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D\&E). The main questions it aims to answer are: * Is cervical preparation with cervical ripening balloon for same-day outpatient D\&E non-inferior to cervical preparation with osmotic dilators? * How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? * How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? Participants will: * Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) * Complete two surveys, one about the cervical preparation and one about the D\&E procedure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
30 milliliter Foley balloon
Dilapan-S
University of New Mexico
Albuquerque, New Mexico, United States
RECRUITINGD&E procedure length (minutes)
From insertion of first instrument to removal of speculum
Time frame: during procedure
Starting dilation (French gauge)
Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)
Time frame: during procedure
Additional dilation (French gauge)
Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)
Time frame: during procedure
Estimated blood loss (milliliters)
Amount of blood loss, measured in milliliters throughout the procedure
Time frame: during procedure
Additional sedation medication administered
yes/no
Time frame: during procedure
Pain (Visual Analog Scale)
10 point visual analog scale with values from 0-10, with 0 being "No pain" and 10 being "Worst possible pain." Electronic slider measure so participants can specify up to 0.001 value.
Time frame: during procedure
Administration of uterotonic medications
yes/no
Time frame: during procedure
Cervical laceration
yes/no
Time frame: during procedure
Estimated blood loss > 500 milliliters
yes/no
Time frame: From enrollment to 24 hours after enrollment
Hospital transfer
yes/no
Time frame: From enrollment to 24 hours after enrollment
Feasibility of cervical preparation (physician-reported)
Yes/ No: "Is this type of cervical prep feasible for future patients" and qualitative free-text responses
Time frame: From enrollment to 24 hours after enrollment
Likelihood to recommend cervical preparation (participant-reported)
Modified Likert scale: Very unlikely, Somewhat unlikely, Neither likely nor unlikely, Somewhat likely, Very likely
Time frame: From enrollment to 24 hours after enrollment
Acceptability of cervical preparation (physician-reported)
Yes/ No: "Is this type of cervical prep acceptable for future patients" and qualitative free-text responses
Time frame: From enrollment to 24 hours after enrollment
Satisfaction with level of pain management (participant-reported)
Yes/ No: "Are you satisfied with your level of pain management..." and qualitative free-text responses
Time frame: From enrollment to 24 hours after enrollment
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