PregnancyNITANCT07361380
Non-Invasive Testing Device for Anaemia
An observational study of Pregnancy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Participants who are pregnant.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Pregnant
- Aged 16-50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, OX39DU
Winok Lapidaire, PhD, +44(0)1865 226845, winok.lapidaire@cardiov.ox.ac.uk
Paul Leeson, PhD FRCP FESC, +44(0)1865 226845, paul.leeson@cardiov.ox.ac.uk
About this study
Official title: Non-Invasive Testing of Blood Biomarkers in Pregnant Women
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. The investigators 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. The 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.
Read the detailed description
Anaemia arises from a reduction in the number of healthy red blood cells or the level of haemoglobin necessary to transport oxygen effectively throughout the body. It is a significant global health concern, affecting 1.6 billion individuals worldwide and untreated anaemia can contribute to chronic heart failure and chronic kidney disease. Anaemia is common among pregnant women. Mild cases of anaemia often go unnoticed due to their nonspecific symptoms, such as fatigue, headaches, and hair loss. Furthermore, studying this disease can be difficult as, particularly in places without ready access to laboratory blood sample analysis as current point-of-care solutions are not able to distinguish between different types of anaemia and prescribe suitable treatments. 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 biases related to poor standardisation of assays and low sample quality.
The investigators 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. The device, named The Vascular Imaging Tool for the Auricle (VITA), utilises high-resolution imaging technology to capture detailed images of blood cells and small vessels within the human body. Unlike existing non-invasive devices that can only measure properties in bulk tissue samples, VITA can analyse characteristics of hundreds of individual cells, thereby facilitating rapid point-of-care testing for iron deficiency anaemia. VITA is a low-cost device, and its unique ability to measure these parameters without requiring consumables or trained operators makes it particularly well-suited for researching anaemia in a range of settings, including low- and middle-income countries.
This project is a proof-of-concept study to assess VITA's performance of Hb testing. Secondary objectives include testing VITA's ability to identify iron deficiency anaemia against the clinical gold standard of laboratory blood tests, identification of other frequently measured blood biomarkers, and identification of biomarkers for long-term health. This study is not collecting data for licensing of the device.
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Haemoglobin, Anaemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants who are pregnant. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Hb measured by VITA with Hb measured by blood sample analysis
Agreement between the two measurements as calculated by systemic error (bias), and 95% limits of agreement as bias ±2 SD concentration of haemoglobin in the blood in g/dl of VITA and blood sample analysis
Measured: Baseline
Secondary outcomes (3)
To determine the maximum accuracy of VITA in detecting iron deficiency anaemia as compared to diagnosis based on guidelines on full iron studies in blood sample analysis
Accuracy of VITA algorithmic diagnosis (yes/no) compared to diagnosis (yes/no) based on haemoglobin, soluble transferrin receptor (sTfR), RDW (red cell distribution width), ferritin, serum iron, transferrin saturation (TSAT), mean corpuscular volume (MCV) and/or mean corpuscular haemoglobin concentration (MCHC)
Measured: Baseline
To train image processing software to detect biomarkers that are frequently used in clinical practice based on VITA images
Correlation of VITA algorithmic metrics and blood sample analysis metrics of the following biomarkers:
- Folate
- Renal function
- Electrolytes
- Liver function
- Calcium phosphate
- Thyroid function
- Full blood count
- Glucose
- Insulin
- Lipids
- HbA1C
Measured: Baseline
To predict long-term health outcomes from features in VITA images
Medical records will be checked up to 6 months post-partum to check for the following indications:
- Hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, HELLP)
- Other pregnancy complications
- Blood pressure
- Post-partum medical complications
Measured: 6 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start28 Oct 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361380
- Sponsor's protocol ID
- 24/WS/0122
- Acronym
- NITA
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Testing of Blood Biomarkers in Pregnant Women
- ClinicalTrials.gov ID
- NCT07361380
- Acronym / sponsor ID
- NITA / 24/WS/0122
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Haemoglobin, Anaemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators 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. The 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.
Detailed description
Anaemia arises from a reduction in the number of healthy red blood cells or the level of haemoglobin necessary to transport oxygen effectively throughout the body. It is a significant global health concern, affecting 1.6 billion individuals worldwide and untreated anaemia can contribute to chronic heart failure and chronic kidney disease. Anaemia is common among pregnant women. Mild cases of anaemia often go unnoticed due to their nonspecific symptoms, such as fatigue, headaches, and hair loss. Furthermore, studying this disease can be difficult as, particularly in places without ready access to laboratory blood sample analysis as current point-of-care solutions are not able to distinguish between different types of anaemia and prescribe suitable treatments. 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 biases related to poor standardisation of assays and low sample quality.
The investigators 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. The device, named The Vascular Imaging Tool for the Auricle (VITA), utilises high-resolution imaging technology to capture detailed images of blood cells and small vessels within the human body. Unlike existing non-invasive devices that can only measure properties in bulk tissue samples, VITA can analyse characteristics of hundreds of individual cells, thereby facilitating rapid point-of-care testing for iron deficiency anaemia. VITA is a low-cost device, and its unique ability to measure these parameters without requiring consumables or trained operators makes it particularly well-suited for researching anaemia in a range of settings, including low- and middle-income countries.
This project is a proof-of-concept study to assess VITA's performance of Hb testing. Secondary objectives include testing VITA's ability to identify iron deficiency anaemia against the clinical gold standard of laboratory blood tests, identification of other frequently measured blood biomarkers, and identification of biomarkers for long-term health. This study is not collecting data for licensing of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who are pregnant. | – | – |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants who are pregnant.
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Pregnant
- Aged 16-50 years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare Hb measured by VITA with Hb measured by blood sample analysis
Time frame: Baseline
Agreement between the two measurements as calculated by systemic error (bias), and 95% limits of agreement as bias ±2 SD concentration of haemoglobin in the blood in g/dl of VITA and blood sample analysis
3 secondary outcomes
To determine the maximum accuracy of VITA in detecting iron deficiency anaemia as compared to diagnosis based on guidelines on full iron studies in blood sample analysis
Time frame: Baseline
To train image processing software to detect biomarkers that are frequently used in clinical practice based on VITA images
Time frame: Baseline
To predict long-term health outcomes from features in VITA images
Time frame: 6 months post-partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Leeson, PhD FRCP FESC (+44(0)1865 226845, paul.leeson@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare Hb measured by VITA with Hb measured by blood sample analysis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.