New device aims to prevent birth injuries during vaginal delivery

NCT ID NCT03973281

Ongoing Disease control Sponsor: Materna Medical Source: ClinicalTrials.gov ↗

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PELVIC ORGAN PROLAPSE VAGINAL DELIVERY

Contacts and locations

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Locations

Baylor College of Medicine

Houston, Texas, 77030, United States
Christiana Care - Center for Women's & Children's Health

Newark, Delaware, 19718, United States
Columbia University Irving Medical Center

New York, New York, 10032, United States
El Camino Hospital

Mountain View, California, 94040, United States
Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19140, United States
La Follette Ob/Gyn

Greenbrae, California, 94904, United States
Lewis Katz School of Medicine at Temple

Philadelphia, Pennsylvania, 19140, United States
Maximos Ob/Gyn

League City, Texas, 77573, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
New York Presbyterian -Queens (NYPQ)

Flushing, New York, 11355, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States
Rutgers Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States
The Cooper Health System

Camden, New Jersey, 08103, United States
The Healing Sanctuary

Idaho Falls, Idaho, 83404, United States
The Metro Health System

Cleveland, Ohio, 44109, United States
The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States
USF Ob/Gyn

Tampa, Florida, 33606, United States
Univ of Utah Ob/Gyn

Salt Lake City, Utah, 84108, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of California Los Angeles

Los Angeles, California, 90095, United States