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.
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 -
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.
Single group
Perineal protection device
DeviceASISU is a CE-marked, single-use perineal protection device intended for use during the second stage of vaginal childbirth. The device is used according to its intended purpose and Instructions for Use. Following ward-level implementation, application in an individual birth is determined by the responsible clinical staff based on clinical circumstances and routine care and is not mandated in every enrolled participant.
Incidence of Grade 2 Perineal Tears
Proportion of eligible participants with a documented Grade 2 perineal tear. The numerator is the number of eligible participants with a documented Grade 2 perineal tear and the denominator is the number of eligible participants with known perineal tear grade. Grade 3 and Grade 4 perineal tears are not counted as Grade 2 events and will be reported separately and included in exploratory analyses of Grade ≥2 perineal tears.
Incidence of Grade ≥2 perineal tears
Proportion of eligible participants experiencing Grade 2, Grade 3 or Grade 4 perineal tears.
Successful ASISU use
Number and proportion of births in which ASISU use was attempted and successfully completed without device discontinuation.
ASISU non-use
Number and proportion of enrolled eligible births in which ASISU was not used, including documented reasons for non-use.
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