Status:
COMPLETED
Materna Prep Study Phase II
Lead Sponsor:
Materna Medical
Conditions:
Vaginal Delivery
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 o...
Detailed Description
Vaginal delivery is a major risk factor for pelvic floor dysfunction. Clinical aspects of pelvic floor dysfunction include pelvic organ prolapse, sexual dysfunction, and fecal and urinary incontinence...
Eligibility Criteria
Inclusion
- 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
- 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.
- Subject has placenta previa or vasa previa.
- Subject has known significant chromosomal or structural fetal anomalies.
- Subject has a category 2 and/or 3 fetal tracing that is unresolved.
Key Trial Info
Start Date :
September 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2023
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT06126328
Start Date
September 8 2021
End Date
October 12 2023
Last Update
February 5 2024
Active Locations (15)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
El Camino Hospital
Mountain View, California, United States, 94040
4
Christiana Care - Center for Women's & Children's Health
Newark, Delaware, United States, 19718