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NCT03973281 · ClinicalTrials.gov registry record · NA
EASE: The Materna Prep Pivotal Study
A NA study of Pelvic Organ Prolapse and Vaginal Delivery, sponsored by Materna Medical.
- Active
- Registry status
- NA
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT03973281: Active NA study of Pelvic Organ Prolapse and Vaginal Delivery, sponsored by Materna Medical.
NCT03973281 is a NA study of Pelvic Organ Prolapse and Vaginal Delivery that is active but no longer recruiting, run by Materna Medical. The registered enrollment target is 420 participants, above the 135-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (211% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03973281, a NA study of Pelvic Organ Prolapse and Vaginal Delivery, is active but no longer recruiting, sponsored by Materna Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Use transperineal ultrasound to identify levator ani muscle detachment
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 |
What the registry record for NCT03973281 still lists
NCT03973281 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (211% higher).
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.
NCT03973281 names 20 study sites across 13 states, led by California, New Jersey, New York.
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.
What interventions are being tested in trial NCT03973281?
The interventions under investigation include: Standard of Care (SOC) (OTHER), Materna Prep Device (DEVICE).
Who is sponsoring clinical trial NCT03973281?
This trial is sponsored by Materna Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03973281's enrollment target sits among peer trials
420 2nd of 40 the highest of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Organ Prolapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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