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

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023698%3A_____%2F25%3AN0000002" target="_blank" >RIV/00023698:_____/25:N0000002 - isvavai.cz</a>

  • Alternative codes found

    RIV/00216224:14110/25:00140930 RIV/00216208:11120/25:43928209 RIV/65269705:_____/25:00081713

  • Result on the web

    <a href="https://www.nature.com/articles/s41598-025-92392-z" target="_blank" >https://www.nature.com/articles/s41598-025-92392-z</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1038/s41598-025-92392-z" target="_blank" >10.1038/s41598-025-92392-z</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

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

  • Original language description

    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-validation for automated analysis. Accuracy, sensitivity, and specificity. 30 women were allocated to group A, 61 to group B, and 61 to group C. The diagnostic outcome was determined for 147 participants. The accuracy, sensitivity, and specificity of the ML-assisted impedance spectroscopy were 87.0 +/- 0.5%, 90.6 +/- 2.0%, and 84.6 +/- 1.9%, respectively, compared with EAUS. After data cleaning, the performance metrics of the proposed final ML model for ONIRY were: 90.0 +/- 0.4%, 90.0 +/- 1.2%, and 90.0 +/- 0.7%, respectively. No adverse device effects or deficiencies were observed. By enabling early identification of sphincter injuries, ML-assisted impedance spectroscopy facilitates timely diagnosis and intervention, potentially reducing long-term complications such as faecal incontinence. Its rapid, bedside application in obstetric settings supports immediate postpartum care, complementing digital rectal examination and optimizing clinical decision-making.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30214 - Obstetrics and gynaecology

Result continuities

  • Project

  • Continuities

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Others

  • Publication year

    2025

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    SCIENTIFIC REPORTS

  • ISSN

    2045-2322

  • e-ISSN

    2045-2322

  • Volume of the periodical

    15

  • Issue of the periodical within the volume

    1

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    13

  • Pages from-to

    7522

  • UT code for WoS article

    001436277100005

  • EID of the result in the Scopus database

    2-s2.0-86000102572