Clinical Research Directory

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

Sponsor: oasicare ApS

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 Conformité Européenne (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 following ward-level implementation of ASISU. ASISU will be used within its intended purpose and according to the Instructions for Use. Although ASISU is prospectively introduced at ward level as part of the study, use of ASISU in an individual birth remains subject to clinical judgment and is not mandated in every enrolled participant. The study will evaluate implementation of ASISU in routine maternity care and clinical outcomes, including Grade 2 perineal tears. Outcomes following implementation will be compared descriptively with eligible historical pre-implementation routine-care data.

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

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