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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
NA trial 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 Sphincter (Anal); Perineal Rupture, Obstetric in 110 participants. Not yet recruiting.
16 September 2027
Quick facts
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 110 |
| Start date | 16 March 2026 |
| Primary completion | 16 September 2027 |
| Estimated completion | 16 September 2027 |
Drugs / interventions 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
Conditions studied
- Sphincter (Anal); Perineal Rupture, Obstetric — all drugs for Sphincter (Anal); Perineal Rupture, Obstetric →
Sponsor
IRCCS San Raffaele — full company profile →
Who can join
18 and older, female only, with Sphincter (Anal); Perineal Rupture, Obstetric. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07474012
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07474012 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele
- Last refreshed: 16 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07474012.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing