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The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-Sâ„¢ plus buccal misoprostol to overnight cervical preparation using Dilapan-Sâ„¢ before D&E at 16.0 to 20.0 weeks.
Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-Sâ„¢ plus buccal misoprostol is non-inferior to overnight Dilapan-Sâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same-day Dilators | Active Comparator | Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D&E. |
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| Overnight dilators | Active Comparator | Participants will have Dilapan-S cervical dilators placed the day prior to their D&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D&E. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Same-Day Dilapan-S | Device | Dilapan-S cervical dilators placed the same day as the D&E procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | From initiation of D&E procedure to completion of D&E procedure, Study Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ila Dayananda | Planned Parenthood of Greater New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of Greater New York | New York | New York | 10012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35675611 | Derived | Kim CS, Dragoman M, Porsch L, Markowitz J, Lunde B, Stoffels G, Dayananda I. Same-Day Compared With Overnight Cervical Preparation Before Dilation and Evacuation Between 16 and 19 6/7 Weeks of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1141-1144. doi: 10.1097/AOG.0000000000004790. Epub 2022 May 2. |
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| Overnight Dilapan-S | Device | Dilapan-S cervical dilators placed the day prior to D&E procedure |
|