Materna Prep Study Phase II (NCT06126328) | Clinical Trial Compass
CompletedPhase 2
Materna Prep Study Phase II
United States214 participantsStarted 2021-09-08
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 3 months from the time of the use of the device during delivery with optional long-term follow-up.
Who can participate
Age range18 Years
SexFEMALE
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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.
✓. 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.
What they're measuring
1
The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imagingmuscle diagnosed via ultrasound imaging
✕. 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.