NCT07474012

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sphincter (Anal); Perineal Rupture, Obstetric

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopy	Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and a rectal examination with machine learning-assisted electrical impedance spectroscopy within the first hour postpartum: the examination will be performed by a gynecologist or a midwife. If an obstetric anal sphincter injury (OASI) is considered as detected women will be managed in line with local practice for OASI. In case primary surgical repair is decided, it should be carried out within 12 hours postpartum. A follow-up visit will be performed within 12 weeks postpartum. During this visit endoanal ultrasound will be performed and anal continence evaluated using Wexner score.

Timeline

• Start date: 2026-03-16
• Primary completion: 2027-09-16
• Completion: 2027-09-16
• First posted: 2026-03-16
• Last updated: 2026-03-16