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New device aims to prevent birth injuries during vaginal delivery

NCT ID NCT03973281

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 01, 2026 · Updated 2 times

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

420 people

The number who actually took part.

Started

Dec 2019

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Criteria for inclusion 1. Subject is scheduled for vaginal birth. 2. Subject is gestating a single fetus. 3. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation. 4. Subject is able and willing to comply with the protocol required follow-up visits. 5. Subject is able and willing to provide written informed consent prior to enrollment. 6. 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. 7. Subject receives epidural anesthesia during labor prior to enrollment. 8. Subject is 18 years of age or older at time of consent. Exclusion Criteria: Criteria for exclusion 1. Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital. 2. Subject is planning or requires a Caesarean-section prior to randomization. 3. Subject begins labor with less than 36 weeks gestation. 4. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury. 5. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome. 6. Subject has a localized (genital tract) or systemic infection. 7. Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery. 8. 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. 9. Subject has placenta previa or vasa previa. 10. Subject has known significant chromosomal or structural fetal anomalies. 11. Subject has a category 2 and/or 3 fetal tracing that is unresolved. 12. Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.

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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

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

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