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EASE: The Materna Prep Pivotal Study
NCT03973281 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Standard of Care (SOC)
- DEVICE Materna Prep Device
Study Locations (20)
California
- La Follette Ob/Gyn — Greenbrae
- University of California Los Angeles — Los Angeles
- El Camino Hospital — Mountain View
New Jersey
- The Cooper Health System — Camden
- Rutgers Robert Wood Johnson University Hospital — New Brunswick
- Rutgers New Jersey Medical School — Newark
New York
- New York Presbyterian -Queens (NYPQ) — Flushing
- Columbia University Irving Medical Center — New York
Ohio
- The Metro Health System — Cleveland
- The Ohio State University Wexner Medical Center — Columbus
Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia
- Lewis Katz School of Medicine at Temple — Philadelphia
Alabama
- University of Alabama at Birmingham — Birmingham
Delaware
- Christiana Care - Center for Women's & Children's Health — Newark
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2026-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03973281
The ClinicalTrials.gov registry entry for NCT03973281 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Materna Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions — of which Standard of Care (SOC) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03973281 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New Jersey, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03973281 about?
NCT03973281 is a clinical study titled "EASE: The Materna Prep Pivotal Study". 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...
What is the current status of trial NCT03973281?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 420 participants. The study started on 2019-12-11. Estimated completion is 2026-08-30.
What conditions does trial NCT03973281 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse, Vaginal Delivery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03973281?
The interventions under investigation include: Standard of Care (SOC) (OTHER), Materna Prep Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03973281?
This trial is sponsored by Materna Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03973281 being conducted?
This trial has 20 study locations across Alabama, California, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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