Evaluating a device to reduce pelvic muscle injuries during vaginal delivery

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery

This study tests a new device that helps protect pelvic muscles during vaginal delivery to see if it can make childbirth safer for new moms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Materna Medical (Industry-sponsored)
• Locations: 15 sites (Birmingham, Alabama and 14 other locations)
• Trial ID: NCT03973281 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and effectiveness of the Materna Prep Device, which is designed to reduce pelvic muscle injuries during vaginal delivery. Participants are randomly assigned to receive either the Materna Prep Device or standard care during the first stage of labor. The device is a single-use, semi-automated dilator that pre-stretches the vaginal canal and surrounding tissues to minimize trauma during delivery. The study aims to follow participants for 12 months post-delivery to evaluate outcomes related to pelvic floor health.

Who should consider this trial

Good fit: Ideal candidates are nulliparous women scheduled for vaginal delivery with an epidural.

Not a fit: Patients planning to have a cesarean delivery or those with a high likelihood of limited dilation time will not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly reduce the incidence of pelvic floor dysfunction in women after vaginal delivery.

How similar studies have performed: Previous feasibility studies have shown promising results with similar approaches, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama and 14 other locations

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

Study contacts

• Study coordinator: Josh Freeman

Conditions Vaginal Delivery; Pelvic Organ Prolapse; Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention