Clinical Trial: Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice

U.S., Sept. 29 -- ClinicalTrials.gov registry received information related to the study (NCT07844005) titled 'Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice' on Sept. 18.

Brief Summary: This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth. ASISU is a Conformite Europeenne (CE)-marked medical device, single-use medical device intended to provide perineal protection during the second stage of vaginal childbirth.

Approximately 280 nulliparous participants undergoing eligible vaginal birth at >=37 weeks of gestation will be prospectively enrolled fol...