Non-invasive anaemia test for pregnant people using ear imaging
Non-Invasive Testing of Blood Biomarkers in Pregnant Women
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford) |
| Trial ID | NCT07361380 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Pregnant individuals aged 16–50 who can give informed consent and do not have ear piercings that prevent imaging are ideal candidates.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Oxford
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.