ACTIVE_NOT_RECRUITING

EASE: The Materna Prep Pivotal Study

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Conditions

Vaginal DeliveryPelvic Organ ProlapsePelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-12-11
Study Completion:2026-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03973281

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is scheduled for vaginal birth.
  2. 2. Subject is gestating a single fetus.
  3. 3. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
  4. 4. Subject is able and willing to comply with the protocol required follow-up visits.
  5. 5. Subject is able and willing to provide written informed consent prior to enrollment.
  6. 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. 7. Subject receives epidural anesthesia during labor prior to enrollment.
  8. 8. Subject is 18 years of age or older at time of consent.
  1. 1. Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
  2. 2. Subject is planning or requires a Caesarean-section prior to randomization.
  3. 3. Subject begins labor with less than 36 weeks gestation.
  4. 4. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
  5. 5. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
  6. 6. Subject has a localized (genital tract) or systemic infection.
  7. 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. 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. 9. Subject has placenta previa or vasa previa.
  10. 10. Subject has known significant chromosomal or structural fetal anomalies.
  11. 11. Subject has a category 2 and/or 3 fetal tracing that is unresolved.
  12. 12. Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.

Contacts and Locations

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
El Camino Hospital
Mountain View, California, 94040
United States
Christiana Care - Center for Women's & Children's Health
Newark, Delaware, 19718
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
The Cooper Health System
Camden, New Jersey, 08103
United States
Rutgers Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
The Metro Health System
Cleveland, Ohio, 44109
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19140
United States
Lewis Katz School of Medicine at Temple
Philadelphia, Pennsylvania, 19140
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Materna Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-11
Study Completion Date2026-08-30

Study Record Updates

Study Start Date2019-12-11
Study Completion Date2026-08-30

Terms related to this study

Keywords Provided by Researchers

  • Pelvic Floor Health, levator ani muscle injury, Pelvic Muscle Injury, Vaginal Delivery, Complications, Childbirth, prevention

Additional Relevant MeSH Terms

  • Vaginal Delivery
  • Pelvic Organ Prolapse