EASE: The Materna Prep Pivotal Study
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
1 other identifier
interventional
420
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 4, 2019
CompletedStudy Start
First participant enrolled
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
September 17, 2025
September 1, 2025
6.6 years
May 31, 2019
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
Use transperineal ultrasound to identify levator ani muscle detachment
3-month Follow-up
The occurrence of pelvic muscle injury, defined as complete detachment of the levator ani muscle diagnosed via ultrasound imaging
Use transperineal ultrasound to identify levator ani muscle detachment
12-month Follow-up
Secondary Outcomes (17)
The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging
3-Month Follow-up
The occurrence of pelvic muscle injury, defined as complete or partial detachment of the levator ani muscle diagnosed via ultrasound imaging
12-Month Follow-up
Length of 2nd Stage Labor
Intra-Procedure
Levator Hiatal Area
3-month and 12-month Follow-up
Perineal Lacerations
Intra-Procedure
- +12 more secondary outcomes
Study Arms (2)
Materna Prep Device
ACTIVE COMPARATORMaterna Prep Device
Standard of Care (SOC)
OTHERStandard of Care (SOC)
Interventions
Eligibility Criteria
You may qualify if:
- Subject is scheduled for vaginal birth.
- Subject is gestating a single fetus.
- Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
- Subject is able and willing to comply with the protocol required follow-up visits.
- Subject is able and willing to provide written informed consent prior to enrollment.
- 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.
- Subject receives epidural anesthesia during labor prior to enrollment.
- Subject is 18 years of age or older at time of consent.
You may not qualify if:
- Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
- Subject is planning or requires a Caesarean-section prior to randomization.
- Subject begins labor with less than 36 weeks gestation.
- Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
- Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
- Subject has a localized (genital tract) or systemic infection.
- Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
- 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.
- Subject has placenta previa or vasa previa.
- Subject has known significant chromosomal or structural fetal anomalies.
- Subject has a category 2 and/or 3 fetal tracing that is unresolved.
- Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Materna Medicallead
- University of Michigancollaborator
Study Sites (22)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
La Follette Ob/Gyn
Greenbrae, California, 94904, 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
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
USF Ob/Gyn
Tampa, Florida, 33606, United States
The Healing Sanctuary
Idaho Falls, Idaho, 83404, 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
New York Presbyterian -Queens (NYPQ)
Flushing, New York, 11355, 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
Maximos Ob/Gyn
League City, Texas, 77573, United States
Univ of Utah Ob/Gyn
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The physician reading all ultrasound images will be blinded to randomization
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 4, 2019
Study Start
December 11, 2019
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
September 17, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
General demographic data and outcome measures will be made available to other researchers