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 use of 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 with a unique ultrasound to check on your pelvic floor muscles.

One year after delivery

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