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

Kód výsledku v 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>

Nalezeny alternativní kódy

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

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

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

Název periodika

SCIENTIFIC REPORTS

ISSN

2045-2322

e-ISSN

2045-2322

Svazek periodika

15

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

13

Strana od-do

7522

Kód UT WoS článku

001436277100005

EID výsledku v databázi Scopus

2-s2.0-86000102572