EASE: The Materna Prep Pivotal Study

Description

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 12 months from the time of the use of the device during delivery.

Conditions

Vaginal Delivery, Pelvic Organ Prolapse

Talk to us

Study Overview

On this page

Study Details

Study overview

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 12 months from the time of the use of the device during 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

EASE: The Materna Prep Pivotal Study

Condition
Vaginal Delivery
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Mountain View

El Camino Hospital, Mountain View, California, United States, 94040

Newark

Christiana Care - Center for Women's & Children's Health, Newark, Delaware, United States, 19718

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Camden

The Cooper Health System, Camden, New Jersey, United States, 08103

New Brunswick

Rutgers Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States, 08901

Newark

Rutgers New Jersey Medical School, Newark, New Jersey, United States, 07103

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Cleveland

The Metro Health System, Cleveland, Ohio, United States, 44109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Materna Medical,

Study Record Dates

2024-12-30