Table of Contents
ISRN Obstetrics and Gynecology
Volume 2013 (2013), Article ID 173278, 5 pages
http://dx.doi.org/10.1155/2013/173278
Clinical Study

Effectiveness of a Novel Device in the Reduction of Cesarean Deliveries

Chief of Obstetrics, Niagara Falls Memorial Medical Center, 621 10th Street Hodge 3, Niagara Falls, NY 14301, USA

Received 17 June 2013; Accepted 31 July 2013

Academic Editors: M. Friedrich and M. Kühnert

Copyright © 2013 Daniel A. Burns. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. To test the hypothesis that the use of the HEM-AVERT Perianal Stabilizer will result in a reduction of cesarean births and shorter duration of second-stage labor. Study Design. In a prospective controlled trial, 102 women scheduled for vaginal delivery were randomized to either the HEM-AVERT investigational device or control group. Ninety eight (98) patients completed the study. A chi-square test was used to evaluate the difference in the number of cesarean deliveries between the investigational and control groups. Duration of second-stage labor was assessed as a secondary outcome. Results. Six (6) of the 50 patients in the investigational group (12%) failed to deliver vaginally and required cesarean delivery. Comparatively, 19 of the 48 control patients (39.6%) required cesarean delivery. Duration of second-stage labor was shorter in the investigational group, but the difference was not statistically significant. Results from 4 patients were excluded due to protocol violations. Conclusion. The HEM-AVERT device effectively reduced the incidence rate of cesarean deliveries in the investigational group when compared to women who delivered without use of the device. This trial is registered with ClinicalTrials.gov NCT01739543.