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Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.
This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D&E) procedures. Pain levels and medication usage will also be assessed following the D&E procedure itself, up to 7 days after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dilapan-S | Active Comparator | Synthetic osmotic dilator |
|
| Laminaria | Active Comparator | Seaweed-based osmotic dilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilapan-S | Device | Synthetic osmotic dilator |
| |
| Laminaria |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain above baseline following Laminaria versus Dilapan-S placement | Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement | First 24 hours after dilator placement |
| Time of maximum pain above baseline following Laminaria versus Dilapan-S placement | Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement | First 24 hours after dilator placement |
| Measure | Description | Time Frame |
|---|---|---|
| Pain medication use after Laminaria versus Dilapan-S placement | Timed surveys of pain medication usage at 2 hours, 4 hours, 8 hours, and approximately 24 hours after dilator placement | First 24 hours after dilator placement |
| Maximum pain increase over baseline following D&E procedure |
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Inclusion Criteria:
Exclusion Criteria:
- chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center Obstetrics and Gynecology | Albany | New York | 12208 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 22, 2022 | Mar 17, 2022 | 3 |
Participants will be randomly assigned to receive one of two existing dilator times, with the remainder of care and study procedures being identical.
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Participants will not know what type of dilator they have been assigned, however the medical care team (including investigators) will be aware.
| Device |
Seaweed-based osmotic dilator |
|
Timed surveys measuring pain on Numeric Rating Scale (0-10), administered at 1 hour, 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure |
| First week after D&E |
| Pain medication use after D&E | Timed surveys of pain medication usage, administered at 4 hours, 24 hours, 48 hours, and 1 week after D&E procedure | First week after D&E |