Effectiveness of a Novel Device in the Reduction of Cesarean Deliveries

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. 1. Introduction The rate of cesarean delivery has risen steadily in the United States since 1996 and currently ranks as the most common surgical procedure performed on women with published estimates ranging from 1.3 to 1.4 million procedures annually [1]. Preliminary numbers released in the National Vital Statistics Reports (October 2012) indicated that the US cesarean rate in 2011 was 32.8%, unchanged from 2010 [2]. The growth in cesarean procedures crosses all demographic boundaries as it is inclusive of all age, racial, ethnic, and economic groups. Attempts at trial of labor (TOL) declined during this same time period. Branch and Silver examined first-birth experiences and found the primary cesarean rate increased from 23.9% in 1990 to 27.1% in 2003 [3]. They noted that among women falling into the low-risk category (delivering at term with singleton vertex presentation), they encountered a 20% increase in cesarean deliveries during the same time period from 19.6% to 23.5%. Solheim et al. postulated that if the cesarean rate continues its ascent at the current rate, cesarean deliveries will account for 56% of all deliveries by 2020 [4]. Additionally, several studies have examined the cesarean rates among patients with active management of labor. Active management includes patient education, commitment to stay with the