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Materna Prep Study Phase II

NCT06126328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-02-05

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 3 months from the time of the use of the device during delivery with optional long-term follow-up.

Conditions

  • Vaginal Delivery
  • Pelvic Organ Prolapse

Interventions

DEVICE

Materna Prep Device

Subjects are treated with Materna Prep Device prior to vaginal delivery

Sponsors & Collaborators

  • Materna Medical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-08
Primary Completion
2023-03-23
Completion
2023-10-12
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06126328 on ClinicalTrials.gov