NITA (Non-Invasive Testing of blood biomarkers in pregnAnt women)

Study Background

Anaemia (iron deficiency) arises from a reduction in the number of healthy red blood cells or the level of haemoglobin (Hb) (a protein inside red blood cells) necessary to effectively transport oxygen throughout the body. Anaemia is common among pregnant women. The gold standard for anaemia diagnosis still relies on laboratory blood tests, which come with limitations in terms of point-of-care capability, accessibility and quality. We have developed a portable and user-friendly device capable of detecting anaemia rapidly and non-invasively and facilitating appropriate treatment by distinguishing anaemia due to iron deficiency from other causes. Our device, named The Vascular Imaging Tool for the Auricle (VITA), utilises high-resolution imaging technology to capture detailed images of blood cells and small blood vessels within the human body. The objectives of this study are to assess VITA's performance of (haemoglobin (Hb)) testing and its ability to identify iron deficiency anaemia against the clinical gold standard of laboratory blood tests.

Study Objectives

We look to recruit 300 women who are pregnant and who have registered with Oxford University Hospitals NHS Foundation Trust for their booking visit. The study visit will take place at any point during the participant's pregnancy.

Study measures to be performed are:

• Informed Consent
• Ear imaging (non-invasive imaging of the ear using VITA)
• Blood sampling (approx 25mls or 5 teaspoons)
• Electronic medical record review

For further information please contact: vita@cardiov.ox.ac.uk