The EASE study aims to evaluate whether an investigational device, called the “Materna Prep Device”, can make childbirth safer and less likely to cause injury to one of the pelvic floor muscles. When a baby is born through the vagina, it can sometimes cause injuries to one of the muscles in the surrounding area. The [...]

We will be enrolling first time mothers planning to deliver their baby vaginally with the use of an epidural. There are other study entrance criteria too, which a study team member can discuss with you if you are interested in participating.

The purpose of the study is to determine if Materna Prep is associated with these improved outcomes for mothers: Shorten delivery times Prevent pelvic muscle injuries Minimize tearing Reduce the need for instruments used during deliveries (use of vacuum or forceps to deliver your baby) Reduce need for C-Section Improve neonatal outcomes (the baby’s APGAR [...]

As with any device inserted into the vagina, there is the risk of infection and damage to vaginal/perineal tissues and the surrounding muscles. Materna Prep is an investigational medical device, so there may be risks that are unknown at this time. The Materna Prep device has been categorized as a non-significant risk device.

Informed Consent If you are eligible, you will be asked if you are willing to participate in this study. If you agree, you will be asked to sign an Informed Consent Form. Day of Delivery After you receive your epidural and before giving birth, you will be randomized to one of two groups: Participants who [...]

Materna Prep is placed after you have had your epidural, and your clinician will adjust your pain medication as needed. Materna Prep also may be removed quickly if necessary.

Only women who have an epidural are eligible for the study.

Materna Prep can be removed and reinserted at your doctor’s or midwife’s discretion during cervical exams. Also, Materna Prep does not prevent the use of other devices commonly used during labor, such as fetal scalp electrodes or intrauterine pressure catheters.