Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
420 participants
INTERVENTIONAL
2019-12-11
2026-08-30
Brief Summary
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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.
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Detailed Description
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The Materna Prep Device is a single-use, semi-automated dilator used during the first phase of labor in order to prepare the vaginal canal for vaginal delivery. By slowly pre-stretching the vagina and surrounding pelvic tissues during labor, the device is essentially dictating the strain rate of the tissue during labor. In previous feasibility studies, the elastic recovery of the tissue has been shown to be on the order of several hours, allowing the benefits of pre-stretching the vagina and surrounding pelvic tissues to last throughout labor. The device is intended to be removed prior to the initiation of the second stage of labor, for delivery to occur unobstructed.
The target patient population for this study is nulliparous women entering the first phase of labor and scheduled for vaginal delivery with an epidural.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Materna Prep Device
Materna Prep Device
Materna Prep Device
Materna Prep Device
Standard of Care (SOC)
Standard of Care (SOC)
Standard of Care (SOC)
Standard of Care (SOC)
Interventions
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Materna Prep Device
Materna Prep Device
Standard of Care (SOC)
Standard of Care (SOC)
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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University of Michigan
OTHER
Materna Medical
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
La Follette Ob/Gyn
Greenbrae, California, United States
University of California Los Angeles
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
Christiana Care - Center for Women's & Children's Health
Newark, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
USF Ob/Gyn
Tampa, Florida, United States
The Healing Sanctuary
Idaho Falls, Idaho, United States
Mayo Clinic
Rochester, Minnesota, United States
The Cooper Health System
Camden, New Jersey, United States
Rutgers Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
New York Presbyterian -Queens (NYPQ)
Flushing, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
The Metro Health System
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lewis Katz School of Medicine at Temple
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Maximos Ob/Gyn
League City, Texas, United States
Univ of Utah Ob/Gyn
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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MaternaMedical
Identifier Type: -
Identifier Source: org_study_id
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