Abstract / Summary
Obstetric anal sphincter injury (OASI) requires immediate postpartum recognition for primary repair. Diagnosis relies primarily on clinical examination, as endoanal ultrasound (EAUS) is rarely a bedside option. Therefore, objective diagnostic assessment is most needed during the first postpartum hours. However, it is challenging to obtain the anatomically verified data needed to develop diagnostic technologies for this clinical window. We evaluated the translation of a machine-learning-assisted impedance spectroscopy model into its intended immediate postpartum setting. The model lifecycle comprised three sequential phases: V1 development using anatomically verified data from a prospective multicenter study (N=152); V2 real-world adaptation, comprising post-market data collection, retraining (N=144) to adapt to acute physiological tissue changes, and subsequent separate evaluation (N=125); and prospective external validation of V2 in an unseen cohort (N=70). During this separate evaluation, V2 achieved 89.6% accuracy. In external validation, all examinations occurred within 4 hours of birth (94.3% within the first hour). Against subsequent EAUS, V2 achieved 86.2% sensitivity, 92.7% specificity, and 90.0% overall accuracy. The V2 model was prospectively externally validated in its intended immediate-postpartum setting, supporting ML-assisted impedance spectroscopy as an objective adjunct, and not a replacement, to clinical OASI assessment. Further validation is required to confirm generalizability.