New device could spot birth injuries better than finger exam
NCT ID NCT07474012
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test whether a machine learning-assisted device (ONIRY) can detect obstetric anal sphincter injuries (OASI) in first-time mothers after vaginal delivery better than the standard digital rectal exam. 110 women will receive both exams within an hour of giving birth, and results will be confirmed with an ultrasound. The goal is to see if the new method improves detection and helps prevent long-term problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- machine learning-assisted electrical impedance spectroscopy (ONIRY system)
- What this could lead to
- If successful, this could provide a faster, more accurate way to detect anal sphincter injuries after childbirth, potentially reducing long-term complications.
- What could go wrong
- This is a small, early-stage study (110 participants) comparing a new device to standard exam. The device may not prove more accurate, and results may not apply to all women.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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