New device aims to prevent birth injuries during vaginal delivery
NCT ID NCT03973281
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a device called Materna Prep, which is used for 30-90 minutes during early labor to gently stretch the vaginal canal and pelvic floor. The goal is to reduce muscle injuries that can happen during vaginal birth. 420 first-time mothers or those with a prior early pregnancy loss are participating, and they are randomly assigned to use the device or receive standard care. Researchers will check for pelvic muscle damage using ultrasound up to 12 months after delivery.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Materna Prep Device
- What this could lead to
- If it works, this device could reduce pelvic floor injuries during childbirth, potentially lowering the risk of pelvic organ prolapse later in life.
- What could go wrong
- This is a relatively small, early-stage study. The device is used only once during labor, and long-term benefits are not yet proven. There may be discomfort or unforeseen complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Christiana Care - Center for Women's & Children's Health
Newark, Delaware, 19718, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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El Camino Hospital
Mountain View, California, 94040, United States
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19140, United States
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La Follette Ob/Gyn
Greenbrae, California, 94904, United States
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Lewis Katz School of Medicine at Temple
Philadelphia, Pennsylvania, 19140, United States
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Maximos Ob/Gyn
League City, Texas, 77573, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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New York Presbyterian -Queens (NYPQ)
Flushing, New York, 11355, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
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Rutgers Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
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The Cooper Health System
Camden, New Jersey, 08103, United States
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The Healing Sanctuary
Idaho Falls, Idaho, 83404, United States
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The Metro Health System
Cleveland, Ohio, 44109, United States
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The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
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USF Ob/Gyn
Tampa, Florida, 33606, United States
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Univ of Utah Ob/Gyn
Salt Lake City, Utah, 84108, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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University of California Los Angeles
Los Angeles, California, 90095, United States
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Other studies related to the condition(s) this trial covers.
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