EASE: The Materna Prep Pivotal Study
Public ClinicalTrials.gov record NCT03973281. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03973281
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 10, 2019
- Primary completion
- Jul 29, 2026
- Completion
- Jul 29, 2026
- Last update posted
- Aug 30, 2026
2019 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| La Follette Ob/Gyn | Greenbrae | California | 94904 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| El Camino Hospital | Mountain View | California | 94040 | — |
| Christiana Care - Center for Women's & Children's Health | Newark | Delaware | 19718 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| USF Ob/Gyn | Tampa | Florida | 33606 | — |
| The Healing Sanctuary | Idaho Falls | Idaho | 83404 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| The Cooper Health System | Camden | New Jersey | 08103 | — |
| Rutgers Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| New York Presbyterian -Queens (NYPQ) | Flushing | New York | 11355 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| The Metro Health System | Cleveland | Ohio | 44109 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19140 | — |
| Lewis Katz School of Medicine at Temple | Philadelphia | Pennsylvania | 19140 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Maximos Ob/Gyn | League City | Texas | 77573 | — |
| Univ of Utah Ob/Gyn | Salt Lake City | Utah | 84108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03973281, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03973281 live on ClinicalTrials.gov.