Clinical Trial

Digital Rectal Examination vs Machine Learning-assisted Electrical Impedance Spectroscopy for Obstetric Anal Sphincter Injuries' Detection: a Prospective Cohort Study in Primiparous Women Giving Vaginal Childbirth

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The investigator will evaluate the detection rate for Obstetric Anal Sphincter Injuries (OASI) in primiparas having given vaginal childbirth, comparing the sensitivity of methods available in a labour ward setting for rapid detection: standard digital rectal examination (DRE) and Machine Learning-assisted electrical impedance spectroscopy (applied with the ONIRY system). Endoanal Ultrasound (EAUS) is used as the reference standard for diagnosis' confirmation and performed within 12 weeks post-delivery.
Trial Details
NCT Number NCT07474012
Lead Sponsor IRCCS San Raffaele
Conditions Sphincter (Anal); Perineal Rupture, Obstetric
Enrollment 110 participants
Start Date 2026-03-16
Primary Completion 2027-09-16 (estimated)
Study Completion 2027-09-16 (estimated)
Updated on ClinicalTrials.gov 2026-03-16