Results of a Novel Device Designed to Reduce the Occurrence of Hemorrhoids Resulting from Vaginal Deliveries
Posted on: June 8, 2015
US Obstetrics & Gynecology, 2011;6(1):36–8
J. Bradley Stern, MD, Obstetrician and Gynecologist, Women’s Clinic of Northern Colorado
Abstract: The purpose of this study was to prospectively assess the effectiveness of the Hem-Avert® Perianal Stabilizer in reducing the occurrence and/or severity of hemorrhoids and/or thrombosed external hemorrhoids attributable to vaginal delivery. Between July 2007 and May 2009 a total of 98 healthy pregnant women were randomized to either the Hem-Avert or control groups at admission for delivery. Success was based upon the absence of either new hemorrhoids and/or progression of pre-existing hemorrhoids postpartum. All investigational patients delivered without any new occurrence of hemorrhoids. Women exhibiting hemorrhoids at admission and randomized to the Hem-Avert group did not encounter hemorrhoid progression. Thirty-three percent of women, hemorrhoid-free at admission and randomized to the control group, developed hemorrhoids. Women diagnosed with hemorrhoids at admission and randomized to the control group encountered hemorrhoid progression. In this limited study, the Hem-Avert Perianal Stabilizer was shown to prevent new occurrences of hemorrhoids and hindered the progression of existing hemorrhoids during vaginal delivery.
Keywords: Postpartum maternal care, delivery-induced hemorrhoids, thrombosed external hemorrhoids
A portion of the data presented in the US Obstetrics and Gynaecology journal article pertains to outcome claims not approved by the FDA, nor claimed by Plexus Biomedical, Inc.
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