A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery

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Study Type/Phase: Pivotal
Status: Recruiting

The purpose of this study is to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries and the length of the second stage of labor during vaginal delivery. The Materna Prep Device is a single-use, semi-automated dilator used during the first phase of labor. By slowly stretching the vagina and surrounding pelvic tissues during labor, the device dictates the strain rate of the tissue during labor. A randomized control group will undergo labor without the Materna Prep Device and receive standard of care practices. Currently, there are no approved devices or standardized procedures to pre-stretch the pelvic tissues in preparation for vaginal delivery.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Scheduled for vaginal birth
  • Gestating a single fetus
  • Nulliparous, or had a previous pregnancy terminated within 24 weeks gestation
  • Receives epidural anesthesia during labor prior to using the device
  • Aged > 18 years at time of consent
  • Has need for or is planning a Caesarean-section
  • Begins labor with less than 36 weeks gestation

Principal Investigator

Sarah Azad, MD

Sponsor

Materna Medical

NCT Number

NCT03973281

Contact

Michelle Backer, Clinical Research Program Lead
michelle_backer@elcaminohealth.org
650-962-4526

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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