Open Actively Recruiting

EASE: The Materna Prep Pivotal Study

About

Brief 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 Purpose
Other
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

Exclusion Criteria:

Join this Trial

Share:
Study Stats
Protocol No.
21-000156
Category
Pregnancy
Contact
DANA LEVIN-LOPEZ
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT03973281
For detailed technical eligibility, visit ClinicalTrials.gov.