Open Actively Recruiting

EASE: The Materna Prep Pivotal Study


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 3 months from the time of the use of the device during delivery. Subjects who elect to continue participation in the long term follow up portion of the study will extend their time in the study to 10 years.

Primary Purpose
Study Type


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

Criteria for inclusion 1. Subject scheduled for vaginal birth. 2. Subject gestating a single fetus. 3. Subject nulliparous, or had a previous pregnancy terminated within 24 weeks gestation. 4. Subject able and willing to comply with the protocol required follow-up visits. 5. Subjects able and willing to provide written informed consent prior to enrollment. 6. Subject has sufficient mental capacity to: understand the informed consent form (ICF), comply with the protocol requirements, and provide clinically relevant and reliable feedback regarding their experience with the device. 7. Subject receives epidural anesthesia during labor prior to using the device. 8. Subject 18 years of age or older at time of consent.

Exclusion Criteria:

Criteria for exclusion 1. Subject has high likelihood of less than 1 hours of potential device dilation time after she arrives at the hospital 2. Subject has need for or is planning a Caesarean-section 3. Subject begins labor with less than 36 weeks gestation 4. Subject has neurological diseases, e.g. Multiple Sclerosis, that may result in unrelated pelvic disorders or has been diagnosed with HIV. 5. Subject has muscular or skin disorder that affects elasticity of tissue, such as scleroderma or lupus.6. Subject has evidence of local or systemic infection, or has active herpes infection. 7. Subject has any prior surgical procedures to the vaginal anatomy which could lead to pelvic dysfunction, pelvic fractures, or pelvic soft tissue injuries. 8. Subject has any general health condition or systemic disease that may represent, in the opinion of the investigator, a potential increased risk associated with device use or pregnancy. 9. Subject has placenta previa or vasa previa 10. Known significant chromosomal or structural fetal anomalies 11. Category 2 and/or 3 fetal tracing that is unresolved

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
Obstetrics & Gynecology
Karla Munoz
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
For detailed technical eligibility, visit