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

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.

Inclusion Criteria: * Nulliparous participant * Gestational age ≥37 completed weeks * Eligible for vaginal birth * Meets predefined study eligibility criteria -Written informed consent obtained before study-specific data collection - Exclusion Criteria: * Birth requiring or proceeding to instrumental intervention for the primary efficacy endpoint. If such a conversion occurs after consent, the reason may still be summarized as an implementation interruption where recorded. * Known perineal abnormality or complication incompatible with ASISU use or requiring surgical intervention during delivery. * Births involving episiotomy. * Planned caesarean section or intrapartum conversion to caesarean section for the clinical efficacy analysis. * Birth in water. * Genital warts (HPV/condylomata) affecting the perineal area. * Perineal varices. * Active genital herpes outbreak. * Known hypersensitivity or intolerance to ASISU device materials or adhesive. * For the prospective observational cohort: inability or unwillingness to provide valid informed consent excludes the individual from enrolment and from inclusion of her individual-level data in the study dataset. It does not, in itself, constitute a clinical contraindication to routine use of ASISU.