FAQs

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 muscle can get hurt when the baby’s head passes through the vagina, especially when it’s being pushed out. This injury can lead to problems after childbirth like pelvic organ prolapse which includes symptoms of vaginal pressure, or feeling a bulge or lump coming out of the vagina.

Right now, there is no proven way to prevent this injury. While there are some different techniques, such as massaging the area around the vagina or using hot packs, they vary a lot in how they’re done and when they’re used, and their effectiveness.

The Materna Prep Device is a tool used during the early stages of labor that gently stretches the vagina and surrounding muscles, which may reduce injury to one of the pelvic floor muscles surrounding the vagina. Essentially, it’s preparing your pelvic floor muscles to handle the strain of childbirth more smoothly, just as you would warm up your muscles before a workout.

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 scores)
• Reduce maternal recovery time

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:

1. Participants who receive Materna Prep (device group), or
2. Participants who deliver without using Materna Prep (control group).

If you are assigned to the device group, Materna Prep will be inserted into your vagina and will gradually expand over about an hour. Before you start pushing, the device will be removed. If you are assigned to the control group, you will deliver without using Materna Prep.

Six weeks after delivery

Data will be collected for the study when you return for your routine 6-week postpartum visit.

Three months after delivery

You will return for a study visit to have a unique ultrasound to check your pelvic floor muscles.

One year after delivery

You will return for a final study visit to have a unique ultrasound to check your pelvic floor muscles.

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.