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
Study Type/Phase: Pivotal
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.
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For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.