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The purpose of this research is to evaluate a new investigational medical device, the Kira device, intended to make it easier for the surgical team to monitor blood loss during and immediately after cesarean deliveries (c-sections). This study will assess the safety of the device and the device's ability to gently suction blood from the uterus into a clear container where it can be seen and measured by the surgical team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | All participants will be assigned to the interventional arm, in which the uterine drain is used to evaluate the blood loss immediately following cesarean delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine drain for use in cesarean section | Device | The intervention will be used to remove uterine contents and measure blood loss immediately following cesarean delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and seriousness of device related Adverse Events (ADE's) | Measured at study exit, approximately 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of use questionnaire | Likert type scale with higher scores indicating agreement with the statement. | Within 2 weeks of study completion |
| Cumulative blood loss | Measured through 24 hours from time of delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
This is a feasibility study for a commercial product.
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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