Materna Prep Study Phase II

Completed · Phase 2

Conditions studied: Vaginal Delivery, Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID: NCT06126328
Run by: Materna Medical
People needed: 214
Starts: 2021-09-08
Expected to finish: 2023-10-12
Last updated by the study team: 2024-02-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
University of California Los Angeles — Los Angeles, California, United States
El Camino Hospital — Mountain View, California, United States
Christiana Care - Center for Women's & Children's Health — Newark, Delaware, United States
Mayo Clinic — Rochester, Minnesota, United States
The Cooper Health System — Camden, New Jersey, United States
Rutgers Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School — Newark, New Jersey, United States
Columbia University Irving Medical Center — New York, New York, United States
The Metro Health System — Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
Lewis Katz School of Medicine at Temple — Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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