EASE: The Materna Prep Pivotal Study

Exclusion Criteria

• •Criteria for exclusion
• •1. Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
• •2. Subject is planning or requires a Caesarean-section prior to randomization.
• •3. Subject begins labor with less than 36 weeks gestation.
• •4. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
• •5. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
• •6. Subject has a localized (genital tract) or systemic infection.
• •7. Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
• •8. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.
• •9. Subject has placenta previa or vasa previa.
• •10. Subject has known significant chromosomal or structural fetal anomalies.
• •11. Subject has a category 2 and/or 3 fetal tracing that is unresolved.
• •12. Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.