A study investigating the influence of the Materna Prep device in first-time moms on pelvic muscle injuries with delivery and the length of the labor.
Goals of Study
To understand if using the Materna Prep device may help:
Prevent pelvic muscle injuries
Minimize tearing
Impact time spent in labor
Learning About Vagina and Pelvic Muscles
Just like stretching before a run, we want to see if using Materna Prep a few hours before delivery will help vagina and pelvic muscles in similar ways.
Funded by The National Institutes of Health (NIH)
CAUTION: Investigationl medical device. Limited by United States law to investigational use.
Study Visits
Day of Delivery
A dedicated research coordinator will work with you during Materna Prep's study. Your OB/GYN or midwife will continue with your clinical care.
Materna Prep is inserted a few hours before giving birth and gradually expands over an hour. Before the baby is delivered, Materna Prep is removed.
Three months after delivery
A follow-up exam and ultrasound will occur, which can coincide with your normal OB/GYN or midwife appointments.
Enrollment
You may qualify if you are a first-time mother who is at least 18-years old, you and your doctor or midwife expect you will deliver at full term, will have a vaginal delivery, and if you plan to use an epidural.
Ask your doctor or midwife if the Materna Prep Clinical Trial is right for you.