EASE: The Materna Prep Pivotal Study

Launched by MATERNA MEDICAL · May 31, 2019

Keywords

ClinConnect Summary

The EASE trial is studying a new device called the Materna Prep Device, which is designed to help reduce pelvic muscle injuries during vaginal delivery. The trial compares the use of this device to standard care, meaning some women will use the Materna Prep Device while others will not. The device will be used for about 30 to 90 minutes during the first stage of labor, and researchers want to see how effective and safe it is for mothers giving birth.

To participate in this study, women need to be at least 18 years old, scheduled for a vaginal birth with a single baby, and able to receive an epidural during labor. They should also be willing to attend follow-up appointments after delivery. The study is currently recruiting participants, and those who join will be involved for about a year after using the device. It's important for potential participants to discuss any medical history or conditions with their doctor to see if they qualify.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Criteria for inclusion
• • 1. Subject is scheduled for vaginal birth.
• • 2. Subject is gestating a single fetus.
• • 3. Subject is nulliparous, or had a previous pregnancy terminated within 24 weeks gestation.
• • 4. Subject is able and willing to comply with the protocol required follow-up visits.
• • 5. Subject is able and willing to provide written informed consent prior to enrollment.
• • 6. In the opinion of the Investigator, the 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 enrollment.
• • 8. Subject is 18 years of age or older at time of consent.
• Exclusion Criteria:
• • Criteria for exclusion
• • 1. Subject has high likelihood of less than 1 hour of potential device dilation time after she arrives at the hospital.
• • 2. Subject is planning or requires a Caesarean-section prior to randomization.
• • 3. Subject begins labor with less than 36 weeks gestation.
• • 4. Subject has a neurological disorder that could cause pelvic floor dysfunction, such as multiple sclerosis or spinal cord injury.
• • 5. Subject has a collagen-associated disorder that affects tissue elasticity, such as scleroderma or Ehlers-Danlos syndrome.
• • 6. Subject has a localized (genital tract) or systemic infection.
• • 7. Subject has a medical history which could lead to pelvic floor dysfunction, such as prior pelvic fractures, pelvic soft tissue injuries, or vaginal surgery.
• • 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. Subject has known significant chromosomal or structural fetal anomalies.
• • 11. Subject has a category 2 and/or 3 fetal tracing that is unresolved.
• • 12. Subject is observed to have friable, denuded, or markedly edematous vaginal tissue during the course of labor.