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

CompletedOBSERVATIONAL
Enrollment

799

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

June 30, 2015

Study Completion Date

September 30, 2015

Conditions
Cesarean Section Rate
Interventions
DEVICE

Hem-Avert Perianal Stabilizer

The HEM-AVERT® Perianal Stabilizer is an FDA approved Class II device in accordance with FDA regulations 21 CFR 801.109. The HEM-AVERT® Perianal Stabilizer is a non-invasive device used to help provide continuous pressure to the perianal region as a means to help provide support during the labor process.

Sponsors
All Listed Sponsors
lead

Desert Perinatal Associates

OTHER

NCT02562547 - Evaluation of the Hem-Avert® Perianal Stabilizer Into Routine Clinical Practice | Biotech Hunter | Biotech Hunter