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EASE: The Materna Prep Pivotal Study

NCT03973281 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2025-09-17

No results posted yet for this 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

  • Vaginal Delivery
  • Pelvic Organ Prolapse

Interventions

DEVICE

Materna Prep Device

Materna Prep Device

OTHER

Standard of Care (SOC)

Standard of Care (SOC)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2026-07-30
Completion
2026-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973281 on ClinicalTrials.gov