Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice

Completed

• Conditions: Cesarean Section Rate
• Interventions: Device: Hem-Avert Perianal Stabilizer

• Registration Number: NCT02562547
• Lead Sponsor: Desert Perinatal Associates

Brief Summary

This is a retrospective data-only study following the phased introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice. The investigators aim to capitalize on the introduction of the HEM-AVERT® Perianal Stabilizer into routine clinical practice in labor and delivery settings in the hospital of Dignity Health - St. Rose, Siena Campus and to determine whether the HEM-AVERT® Perianal Stabilizer reduces the frequency of Cesarean Section during labor and delivery.

Detailed Description

The on label device in this study is the HEM-AVERT® Perianal Stabilizer manufactured by Stetrix, Inc. This study is being sponsored by Dignity Health 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 801.109. Retrospective data will be collected in this study on the reduction of c-section rates and duration of second stage of labor. These data may be used to support an application to the FDA for a new indication of reducing c-sections. It is also possible the second stage labor data may also be used in support of expanded labeling.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-06
• Status Verified: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-27
• Last Update Submitted: 2015-09-27
• Study First Posted: 2015-09-29
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 799

Inclusion Criteria

• Vaginal Births

Exclusion Criteria

• Anticipated non-vaginal birth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Vaginal Births	Hem-Avert Perianal Stabilizer	The application of the Hem-Avert Perianal Stabilizer

Primary Outcome Measures

Name	Time	Method
Cesarean Conversion Rate	90 Days	Cesarean Conversion Rate

Secondary Outcome Measures

Name	Time	Method
Second stage labor times	90 Days	Comparing second stage labor times
Lacerations	90 Days	Comparing lacerations