Condition: Vaginal Delivery · Pelvic Organ Prolapse · Sponsor: Materna Medical
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| 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 | — |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06126328