A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device
Condition: Tear, Pelvic Organ, Obstetric Trauma
Study type: Interventional

Summary: 
      The Materna device aims to prevent pelvic tissue damage by preventing overstretching of
      pelvic floor muscle fibers during delivery. The device is a single use, disposable,
      mechanical dilator that penetrates the first 4 cm or ½ of the vaginal canal and gradually
      expands the vagina from a resting diameter of 2-3 cm to the fully expanded size of a
      delivering fetus, roughly 8-10 cm. The Materna device will be used during the first stage of
      labor, for roughly 1-2 hours, in a hospital Labor and Delivery unit, under the supervision of
      trained clinical labor and delivery providers
    

Detailed description: 
      Over 80% of women who deliver vaginally will sustain a vaginal tear, and roughly half of all
      women will suffer from permanent pelvic muscle damage that may lead to pelvic disorders later
      in life.(1-8) The consequences of vaginal tearing are acute and chronic pain, longer recovery
      times, sexual dysfunction and permanent disfigurement.(1-4) Additionally, women often say
      that the prospect of tearing is one the things they fear most regarding childbirth. Tearing
      during childbirth is well documented as occurring during most deliveries, however there is
      additional damage now being discovered that occurs internally to the pelvic muscles.

      It has long been thought that childbirth is the leading factor contributing to the
      development of pelvic floor disorders such as pelvic organ prolapse, urinary and fecal
      incontinence. (6,9,10) In the last 10 years, new imaging studies have shown that
      approximately 20-30% of women will have their pelvic muscles permanently separated from the
      pelvic bone during vaginal delivery.(5-11) In an additional 20-30% of cases, the muscles may
      remain attached to the pelvic bone but have been stretched to the point of becoming
      functionally compromised

      One of the most promising ideas to prevent this damage is to slowly prepare the pelvic
      muscles, during labor while the cervix is dilating, in order to maximize their stretch.

      The previous data and preliminary findings of Materna suggest the following overall working
      hypotheses:

        1. Vaginal lacerations and pelvic floor muscle damage lead to increased incidence of pelvic
           floor disorders and other negative sequelae.

        2. Vaginal lacerations and pelvic floor muscle damage are caused by over straining of
           pelvic muscles and vaginal tissues without maximizing the tissue strain using
           appropriate viscoelastic relaxation during the second phase of labor.

        3. The incidence and severity of vaginal lacerations and pelvic floor muscle damage can be
           reduced by inducing a more gradual strain of the vaginal tissues using a device-based
           approach

      Currently there are no devices available in the U.S. to protect the pelvic muscles from
      damage during childbirth. The Materna device takes advantage of well-proven biomechanical
      data in the fields of sports medicine and orthopedics showing that tissue is viscoelastic,
      meaning that the more slowly it is stretched the easier it is to stretch. Materna aims to
      take advantage of this biomechanical phenomena as well as the length of the first phase of
      labor to reduce the tension in the tissue, slowly maximizing the stretch of the tissue in
      order to prepare it for a delivery with less injury. There is also evidence showing that
      reducing the tension in the pelvic muscles could lead to a shorter delivery time, resulting
      in a less stressful and healthier delivery for the baby
    

Intervention name(s): Materna Medical
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention