EASE: The Materna Prep Pivotal Study
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
Vaginal delivery is a major risk factor pelvic floor dysfunction. Clinical aspects of pelvic floor dysfunction include pelvic organ prolapse, sexual dysfunction, and fecal and urinary incontinence. Trauma to the pelvic structures occurs as the fetal head passes through the vaginal canal, especially with acute distension at the time of crowning - the exiting of the fetal head.
Currently, there is no standardized approach for preparing the vagina for delivery to avoid trauma and injury to the pelvic ...