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NCT Number: 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

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.

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Key information

Conditions

Sphincter (Anal); Perineal Rupture, Obstetric

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, legally competent woman
  • Freely given written informed consent
  • Pregnant, primigravid, admitted to labour ward and planned for vaginal delivery
  • Woman in the early postpartum period (up to 1 hour postpartum) after the vaginal (spontaneous or assisted) childbirth, of a neonate of birth weight of at least 500 g or, if birth weight does not apply, gestational age of at least 22 completed weeks; if neither of the two applies, the neonate crown-heel length of at least 25cm
  • Absence of any contraindication for use of machine learning-assisted electrical impedance spectroscopy
  • Not currently participating or planned for any other research study related to obstetrics or proctology

Exclusion criteria

  • Active inflammatory bowel disease affecting the perianal area
  • Implants in the pelvic area
  • Major malformations in perianal area or anal prolapse

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. The investigator will evaluate the detection rate for OASI in primiparous women who have completed vaginal delivery comparing standard digital rectal digital rectal examination and machine learning-assisted electrical impedance spectroscopy.

    Time frame: From enrollment to the follow-up visit that will be performed within 12 weeks postpartum

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Salvatore Prof.

CONTACT

[email protected]

0039 3472757131

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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