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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

NCT07474012 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Stefano Salvatore · IRCCS San Raffele

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2027-09-16
Completion
2027-09-16

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474012 on ClinicalTrials.gov