Materna Prep Device for Vaginal Birth

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Materna Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women over 18, expecting a single baby, planning a vaginal birth without prior pelvic surgeries. They must be able to follow the study plan and provide consent. Excluded are those with less than an hour for device use at hospital arrival, planned C-sections, preterm labor before 36 weeks, certain diseases like lupus or MS, infections including HIV or active herpes, placenta issues, fetal anomalies or risky fetal heart patterns.

Inclusion Criteria

I am 18 years old or older.

Subject receives epidural anesthesia during labor prior to using the device.

Subject able and willing to comply with the protocol required follow-up visits.

+13 more

Exclusion Criteria

My unborn baby has been diagnosed with significant genetic or structural abnormalities.

I am likely to need a medical device within 1 hour of arriving at the hospital.

I have had surgery on my vaginal area that could affect my pelvic function.

+9 more

Participant Groups

The EASE study tests the Materna Prep Device against standard care during vaginal births to see if it reduces pelvic muscle injuries. Participants will either use the device once during labor's first stage for up to 90 minutes or receive regular care without it. The involvement lasts about a year from delivery.

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care (SOC)Experimental Treatment1 Intervention

Standard of Care (SOC)

Group II: Materna Prep DeviceActive Control1 Intervention

Materna Prep Device