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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Ripening Balloon | Experimental |
| |
| Osmotic Dilators | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Ripening Balloon | Device | 30 milliliter Foley balloon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| D&E procedure length (minutes) | From insertion of first instrument to removal of speculum | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Starting dilation (French gauge) | Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter) | during procedure |
| Additional dilation (French gauge) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87106 | United States |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Osmotic Dilators |
| Device |
Dilapan-S |
|
Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)
| during procedure |
| Estimated blood loss (milliliters) | Amount of blood loss, measured in milliliters throughout the procedure | during procedure |
| Additional sedation medication administered | yes/no | 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. | during procedure |
| Administration of uterotonic medications | yes/no | during procedure |
| Cervical laceration | yes/no | during procedure |
| Estimated blood loss > 500 milliliters | yes/no | From enrollment to 24 hours after enrollment |
| Hospital transfer | yes/no | 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 | 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 | 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 | 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 | From enrollment to 24 hours after enrollment |