Materna Prep Device for Vaginal Birth

Not currently recruiting at 22 trial locations

Overseen By Josh Freeman

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Materna Medical

Disqualifiers: Neurological disorders, Collagen disorders, Infections, Placenta previa, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Materna Prep Device can prevent pelvic muscle injuries during vaginal births. Participants will receive either the Materna Prep Device or standard care without the device. The Materna Prep Device is used once for about 30-90 minutes during the first stage of labor. Pregnant women expecting one baby and planning a vaginal birth may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve childbirth outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Materna Prep Device is safe for vaginal birth?

Research shows that the Materna Prep Device is designed to help prevent pelvic muscle injuries during childbirth. In earlier studies, the device demonstrated promising results. Specifically, one study found it 100% effective in preventing levator ani muscle avulsion in all women who used it. This suggests that the device is well-tolerated and may be safe during delivery.

Since this trial is in the "Not Applicable" phase, detailed safety information is limited. However, the encouraging earlier results may offer some confidence about the device's safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Materna Prep Device is unique because it offers a new approach to easing vaginal births. Unlike standard care options, which typically involve techniques like perineal massage or controlled pushing, the Materna Prep Device is designed to gently prepare the birth canal by expanding it gradually before labor begins. Researchers are excited about this device because it aims to reduce the risk of injury to both the mother and baby during delivery, potentially leading to shorter recovery times and fewer complications.

What evidence suggests that the Materna Prep Device is effective for reducing pelvic muscle injuries during vaginal delivery?

Research has shown that the Materna Prep Device, which participants in this trial may receive, may help reduce injuries to pelvic muscles during vaginal birth. A previous study found that the device successfully prevented a specific type of pelvic floor injury in all women who used it, suggesting high effectiveness. The device is used briefly during the early part of labor, potentially offering a convenient option for expecting mothers. These early results suggest that the Materna Prep Device could be a helpful tool in making childbirth safer for mothers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

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

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

Subject nulliparous, or had a previous pregnancy terminated within 24 weeks gestation

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

One-time use of the Materna Prep Device during the first stage of labor for 30-90 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after delivery, including assessments at 3-month and 12-month intervals

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Materna Prep Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Standard of Care (SOC) Experimental Treatment 1 Intervention

Standard of Care (SOC)

Group II: Materna Prep Device Active Control 1 Intervention

Materna Prep Device

Who Is Running the Clinical Trial?

Materna Medical

Lead Sponsor

Trials

5

Recruited

930+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Citations

1. maternamedical.com maternamedical.com/press/materna-medical-completes-enrollment-in-ease-trial-of-ellora-obstetrical-system-used-in-first-time-mothers/

Materna Medical Completes Enrollment in EASE Trial of ... The trial enrolled 420 first-time mothers to evaluate the safety and effectiveness of the investigational Ellora™ Obstetrical System for ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03973281

NCT03973281 | EASE: The Materna Prep Pivotal Study This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.

3. mayo.edu mayo.edu/research/clinical-trials/cls-20524070

EASE: The Materna Prep Pivotal Study - Mayo Clinic The purpose of this study is to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/maternas-device-successfully-prevents-pelvic-floor-injury-in-first-time-mothers/

Materna's device successfully prevents pelvic floor injury in ... Materna's vaginal dilator boasted a 100% score of preventing levator ani muscle avulsion in all women treated with the device.

5. maternamedical.com maternamedical.com/data-bibliography/

Data & Bibliography This is a comprehensive catalog of Materna's registered clinical trials and associated peer-reviewed publications. All studies have been conducted within the ...

6. easestudy.org easestudy.org/

Home - EASE: A Study On How To Protect Maternal Pelvic ... The EASE study aims to evaluate whether an investigational device, called the “Materna Prep Device”, can make childbirth safer and less likely to cause injury.