A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer|
- Reduce C-section Rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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
- Reduce duration of 2nd stage of labor. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Subject receives Hem-Avert Device.
Application of Hem-Avert
Other Name: Hem-Avert Perianal Stabilizer
No Intervention: Control
Subject does not receive Hem-Avert Device.
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.
|United States, New York|
|Niagara Falls Memorial Medical Center|
|Niagara Falls, New York, United States, 14301|
|Principal Investigator:||Dan Burns, M.D.||Unafilliated|