A Pilot Study To Evaluate The Preliminary Safety And Feasibility Of The Materna Medical Device

Inclusion Criteria: * Primiparas, or previous pregnancy terminated before 24 weeks gestation * Single fetus birth * Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent * Subject is willing and able to comply with specified follow-up evaluations * Planned to have epidural during birthing process Exclusion Criteria: * Previous delivery, or previous pregnancy beyond 24 weeks gestation * Less than 36 weeks gestation * Neurological diseases e.g. Multiple Sclerosis that may result in unrelated pelvic disorders * Muscular or skin disorder that effects elasticity of tissue such as scleroderma or lupus * Local or systemic infection e.g. HIV, herpes * Diabetes * Clinically estimated fetal weight \> 4,500 grams * Any prior surgical procedures to the vaginal anatomy which could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries. Evaluated during baseline screening * High likelihood of less than 1 hour of potential device dilation time after the woman arrives at the center and receives epidural * A cervical dilation of greater than or equal to 6 cm * BMI \> 32.5 prior to becoming pregnant