NCT02167438

Reducing Cesarean Childbirth Rates Using the Hem-Avert Perianal Stabilizer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Stetrix, Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to evaluate an FDA approved device called the HEM-AVERT® Perianal Stabilizer and the efficacy in reducing the C-section rate and/or reducing the second stage of labor times.

Detailed description

Women may sometimes be reluctant to push resulting in a prolonged second stage labor, which could lead to a Cesarean section. This study will record the frequency of Cesarean sections in two groups to determine if there are any measurable differences. The investigational device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This device has received previous FDA clearance as a Class II device to prevent hemorrhoids during childbirth. This study is being conducted by Stetrix, Inc. and falls within the guidelines set forth by the Food and Drug Administration in 21 CFR Section 812.2 as a non-significant risk study. The HEM-AVERT® Perianal Stabilizer is a Class II device in accordance with FDA regulation 21 CFR 890.5765. The Class II version of the device and the investigational device are identical in terms of materials, design, intended population and area used. The sole difference is that data will be collected in order to support an application to the FDA to obtain clearance of the device for the specific claim of reducing the C-section rate and/or reducing the second stage of labor times. This difference in data collection may be viewed as off-label use of the device although there is no new risk to the subject in the use of this device as an investigational device. The primary objective of this study is to reduce the C-section rate and/or the second stage of labor times while using this device. For patients scheduled for a vaginal delivery, success is defined as completing the vaginal delivery process.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DEVICE	Hem-Avert Perianal Stabilizer

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-06-19
• Last updated: 2017-03-22

Locations

1 site across 1 country: United States