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 floor. There are myriad perineal techniques which can be employed to slow down the birth of the baby’s head and allow the perineum to stretch slowly to prevent injury. Perineal massage, passive descent, hot compresses, and “hands-on” delivery are the most common forms of intervention used to prepare the vagina for delivery however, there is significant variability in the methods, timing, and applied forces.
Studies that have shown that perineal massage reduces the injury rate of tissue are due to stretching the tissue more, over a greater length of time. In a critical review and meta-analysis of the literature, perineal massage performed by introducing the middle and index fingers into the vagina to gently stretch the perineum from side to side, reduces the risk of severe injury to the perineum and pelvic muscles in nulliparous women.
The Materna Prep Device is a single-use, semi-automated dilator used during the first phase of labor in order to prepare the vaginal canal for vaginal delivery. By slowly pre-stretching the vagina and surrounding pelvic tissues during labor, the device is essentially dictating the strain rate of the tissue during labor.
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