The EASE Study
Official Title
A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE MATERNA PREP DEVICE IN REDUCING PELVIC MUSCLE INJURIES DURING VAGINAL DELIVERYPurpose
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
Could this study be right for you?
You may be eligible for this study if you: 1. Are scheduled for vaginal birth. 2. Are pregnant with a single fetus. 3. Haven't given birth previously, or had a previous pregnancy terminated within 24 weeks gestation. 4. Are willing to comply with the protocol required follow-up visits. 5. Are able and willing to provide written informed consent prior to enrollment. 6. Are 18 years of age or older at time of consent. You will be ineligible for this study if you: 1. Have a high likelihood of less than 1 hour of potential device dilation time after you arrive at the hospital. 2. Have a need for or is planning a Caesarean-section. 3. Begin labor with less than 36 weeks gestation. 4. Have a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury 5. Have a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome 6. Have a localized (genital tract) or systemic infection. 7. Have had prior surgical procedures to the vaginal anatomy which could lead to pelvic floor dysfunction, such as pelvic fractures or pelvic soft tissue injuries 8. Have 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. Have placenta previa or vasa previa. 10. Have a known significant chromosomal or structural fetal anomalies. 11. Have a category 2 and/or 3 fetal tracing that is unresolved.