EASE: The Materna Prep Pivotal Study (NCT03973281) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
EASE: The Materna Prep Pivotal Study
United States420 participantsStarted 2019-12-11
Plain-language summary
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device
Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor.
Subject participation in the study is targeted to be 12 months from the time of the use of the device during delivery.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is scheduled for vaginal birth.
. Subject is gestating a single fetus.
. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
. Subject is able and willing to comply with the protocol required follow-up visits.
. Subject is able and willing to provide written informed consent prior to enrollment.
. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience with the device.
. Subject receives epidural anesthesia during labor prior to enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
Timeframe: 3-month Follow-up
2
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
. Subject is 18 years of age or older at time of consent.
Exclusion criteria
. Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
. Subject is planning or requires a Caesarean-section prior to randomization.
. Subject begins labor with less than 36 weeks gestation.
. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
. Subject has a localized (genital tract) or systemic infection.
. Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy.