Dilation and Evacuation
Conditions
Brief summary
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
Interventions
30 milliliter Foley balloon
DEVICEOsmotic Dilators
Dilapan-S
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals who desire outpatient dilation and evacuation (D\&E) * At least 18 years of age * Able and willing to consent * Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound * Able to read and understand English or Spanish * Able to obtain reliable post-procedure transportation * Able to observe fasting guidelines of 6 hours prior to the D\&E procedure
Exclusion criteria
* Medical conditions that require procedural management in the operating room * Preference for D\&E procedure in the operating room
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| D&E procedure length (minutes) | during procedure | From insertion of first instrument to removal of speculum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Starting dilation (French gauge) | during procedure | Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter) |
| Additional dilation (French gauge) | during procedure | Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter) |
| Estimated blood loss (milliliters) | during procedure | Amount of blood loss, measured in milliliters throughout the procedure |
| Additional sedation medication administered | during procedure | yes/no |
| Pain (Visual Analog Scale) | during procedure | 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. |
| Administration of uterotonic medications | during procedure | yes/no |
| Cervical laceration | during procedure | yes/no |
| Estimated blood loss > 500 milliliters | From enrollment to 24 hours after enrollment | yes/no |
| Hospital transfer | From enrollment to 24 hours after enrollment | yes/no |
| Feasibility of cervical preparation (physician-reported) | From enrollment to 24 hours after enrollment | Yes/ No: "Is this type of cervical prep feasible for future patients" and qualitative free-text responses |
| Likelihood to recommend cervical preparation (participant-reported) | From enrollment to 24 hours after enrollment | Modified Likert scale: Very unlikely, Somewhat unlikely, Neither likely nor unlikely, Somewhat likely, Very likely |
| Acceptability of cervical preparation (physician-reported) | From enrollment to 24 hours after enrollment | Yes/ No: "Is this type of cervical prep acceptable for future patients" and qualitative free-text responses |
| Satisfaction with level of pain management (participant-reported) | From enrollment to 24 hours after enrollment | Yes/ No: "Are you satisfied with your level of pain management..." and qualitative free-text responses |
Countries
United States
Outcome results
None listed