Non-invasive anaemia test for pregnant people using ear imaging
Official title: Non-Invasive Testing of Blood Biomarkers in Pregnant Women
Run by University of Oxford · NCT07361380 · Data updated 2026-11-12
This project tests a handheld imaging device called VITA to quickly detect anaemia and tell if it's caused by iron deficiency in pregnant people.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years to 50 Years |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford) |
| Status | Recruiting |
| Started | October 28, 2024 |
| Main results expected | April 30, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07361380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals aged 16–50 who can give informed consent and do not have ear piercings that prevent imaging are ideal candidates.
✕Probably not a fit
People who are not pregnant, who have ear piercings that cannot be removed, or who require immediate laboratory diagnostics for other conditions are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project uses a portable device (VITA) to capture high-resolution images of small blood vessels and cells in the ear (auricle) to estimate haemoglobin and identify iron-deficiency anaemia. Pregnant participants aged 16–50 who can give informed consent and have removable ear piercings will have VITA imaging performed alongside standard laboratory blood tests. The VITA measurements will be compared to gold-standard lab haemoglobin and iron-status tests to measure accuracy and the device's ability to distinguish iron-deficiency from other causes. The overall aim is to validate a rapid, non-invasive point-of-care tool that could improve screening where lab access is limited.
Why it matters
Potential benefit: If successful, VITA could enable rapid, non-invasive anaemia screening during pregnancy and help clinicians target iron treatment without waiting for lab results.
How similar studies have gone: Other non-invasive haemoglobin and smartphone imaging approaches have shown mixed accuracy and typically cannot determine cause, so using auricle vascular imaging to distinguish iron-deficiency is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Pregnant * Aged 16-50 years Exclusion Criteria: * Ear piercings that cannot be temporarily removed that would prevent the ability of the VITA device to take images of the ear blood vessels. * Ear piercings that would be visible on the ear blood vessel images
Where it's running
-
University of Oxford
Oxford, United Kingdom Recruiting
Study contacts
- Study coordinator: Paul Leeson, PhD FRCP FESC
- Email: paul.leeson@cardiov.ox.ac.uk
- Phone: +44(0)1865 226845
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.