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A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.
This study is being conducted to evaluate an existing FDA approved device called the HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing the second stage of labor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational | Experimental | Subject receives Hem-Avert Device. |
|
| Control | No Intervention | Subject does not receive Hem-Avert Device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hem-Avert | Device | Application of Hem-Avert |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduce C-section Rate | The primary objective (purpose) of this study is to evaluate the success rate of the HEM-AVERT® device as a method of reducing C-section rates | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce duration of 2nd stage of labor. | A secondary objective is to evaluate the success rate of the HEM-AVERT® device as a method of reducing the duration of second stage of labor | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Burns, M.D. | Unafilliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niagara Falls Memorial Medical Center | Niagara Falls | New York | 14301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24078876 | Derived | Burns DA. Effectiveness of a novel device in the reduction of cesarean deliveries. ISRN Obstet Gynecol. 2013 Sep 1;2013:173278. doi: 10.1155/2013/173278. eCollection 2013. |
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