Sphincter (Anal); Perineal Rupture, ObstetricNCT07474012
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
A study testing 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 in people with Sphincter (Anal); Perineal Rupture, Obstetric, run by IRCCS San Raffaele.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sphincter (Anal); Perineal Rupture, Obstetric
- What is being tested?
- 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2026to 16 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active inflammatory bowel disease affecting the perianal area
- Implants in the pelvic area
- Major malformations in perianal area or anal prolapse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Primigravid admitted to labour ward for vaginal delivery | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the follow-up visit that will be performed within 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion16 Sep 2027 (estimated)
- Study completion16 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphincter (Anal); Perineal Rupture, ObstetricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Salvatore, IRCCS San Raffaele
- Investigators
- Stefano Salvatore, Principal investigator, IRCCS San Raffele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474012
- Sponsor's protocol ID
- ON-ASY
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07474012
- Acronym / sponsor ID
- ON-ASY
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 16 Sep 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primigravid admitted to labour ward for vaginal delivery | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Active inflammatory bowel disease affecting the perianal area
- Implants in the pelvic area
- Major malformations in perianal area or anal prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primiparous women who have completed vaginal delivery will be submitted to a digital rectal examination and an examination with machine learning-assisted electrical impedance spectroscopyPrimiparous 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. | Diagnostic test | Primigravid admitted to labour ward for vaginal delivery |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefano Salvatore principal investigator
IRCCS San Raffele
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Sphincter (Anal); Perineal Rupture, Obstetric, run by IRCCS San Raffaele.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Salvatore Prof. (0039 3472757131, salvatore.stefano@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.