Qualifying for the Study

What are the enrollment criteria for the study?

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 as well, which a doctor, midwife or study investigator can discuss with you if you are interested in participating.

 

Potential Benefits

What are the potential benefits to participating in the study?

There is the possibility that you may spend less time delivering your baby or minimize tissue tearing. The purpose of the study is to determine if the Materna Prep device is associated with these improved outcomes for mothers.

 

Study Risks

As with any device inserted into the vagina, there is the risk of infection and damage to the surrounding tissue and muscles. The Materna Prep device 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.

 

Study Requirements

What does study participation involve?

A dedicated Research Coordinator and your OB/GYN or midwife will discuss the study with you and determine your desire and eligibility to participate. If you agree to participate, you will be asked to sign an informed consent form. Once you are admitted to the hospital, the Materna Prep device will be inserted into your vagina a few hours before giving birth and will gradually expand over an hour. Before the baby arrives, Materna Prep will be removed. Three months after delivery, you will be asked to attend a follow-up exam and ultrasound, which can coincide with your normal follow up OB/GYN or midwife appointment.

 

Comfort

Will using Materna Prep hurt?

Based on early clinical trial experience to date, the Materna Prep has been well tolerated. Also, you will be under epidural anesthesia when the device is used, so that should prevent any pain from occurring due to use of the device.

 

Epidural

Do you need an Epidural with Materna Prep?

For purposes of consistent data collection during this study, only women planning to use an epidural are eligible for the study.

 

Cervical Exams

Can doctors or midwives do a cervical exam while using Materna Prep?

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, intrauterine pressure catheters, or Cervidil.