EASE: Use of the Maternal Prep device for reducing pelvic muscle injuries during vaginal delivery

MATERNA PREP DEVICE PIVOTAL TRIAL

A study to evaluate the safety and effectiveness of the Materna Prep device for reducing pelvic muscle injuries during vaginal delivery. Also, this study will evaluate whether using the Materna Prep device will shorten the length of the second phase of labor.

 

The goal of the Materna Prep device use is to slowly stretch the muscles in the birth canal by increasing the diameter of the birth canal before the baby is born. The device is intended to stretch the birth canal slowly, as opposed to the more sudden stretching that occurs as the baby travels through the birth canal. This may potentially decrease any damage to the pelvic muscles. The Materna Prep device is inserted into the vagina and will remain in place for approximately thirty to ninety (30-90) minutes and will be removed before delivery begins. The timing for the use of the device is designed to avoid any contact with the baby. The device has a flashing display notification that will let your doctor know if the baby is entering the vaginal canal.

 

In addition to the use of the Materna Prep device, study participants will receive the same standard of care as the patients who are not participating in this study. Patients enrolled in the study will of care as the patients who are not participating in this study. Patients enrolled in the study will undergo a few more questions and assessments prior to discharge.

 

Contact info: 215-940-5550