Detection of obstetric anal sphincter injuries using machine learning-assisted impedance spectroscopy: a prospective, comparative, multicentre clinical study.

ABSTRACT: To evaluate the clinical performance and safety of the ONIRY system for obstetric anal sphincter injuries (OASI) detection versus three-dimensional endoanal ultrasound (EAUS). A prospective, comparative, multicentre, international study. Poland, Czechia, Slovakia, and Spain. 152 women between the first moments up to 8 weeks after vaginal delivery. Participants underwent EAUS and were allocated to groups based on OASIS classification: A (no perineal tear), B (1st or 2nd degree tear), or C (3rd or 4th degree, anal sphincters affected). Electric impedance was measured in the anal canal using the ONIRY system. The primary endpoint was the diagnostic outcome of impedance spectroscopy versus EAUS. Adverse events were collected. Part II involved in silico modelling and 10-time 10-fold cross-valid

SUBMITTER: Borycka K 

PROVIDER: S-EPMC11876446 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature