Non-invasive detection of anaemia in pregnancy V0.2
Research type
Research Study
Full title
Comparison of methods of detection of anaemia: non-invasive screening using pulse CO-oximetry, point-of-care device and conventional laboratory method.
IRAS ID
276139
Contact name
Amarnath Bhide
Contact email
Sponsor organisation
St George's NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Anaemia complicating pregnancy is seen relatively commonly in pregnancy. Diagnosis of anaemia requires obtaining a blood sample from the woman and testing it in the laboratory. Access to sterile needles and syringes, laboratory delivering a reliable and reproducible results are limited. Therefore, a test which does not require a blood sample, is attractive. Non-invasive estimation of haemoglobin is possible with pulse co-oximetry. A commercial device is available (Mesimo Pronto pulse co-oximeter). This technology uses a finger probe, and a blood sample is not necessary.
We will investigate the accuracy of the Pronto device and compare it with the laboratory gold standard as well as estimation using a point-of-care device (HaemoCue).
We will apply the Masimo Pronto pulse oximetry device and record the haemoglobin. A sample of the blood will be obtained in EDTA tube and sent to the laboratory at St. George’s. Additionally, haemoglobin estimation will be performed on a finger-prick sample in the clinic. We aim to validate the technology in 120 pregnant women.
We will also investigate if the technology is dependent on skin pigmentation. The skin pigmentation of the participants will be assessed using validated established categories (Fitzpatrick scale). The accuracy of the pulse co-oximetry will be tested on participants with various skin pigmentation types.REC name
HSC REC A
REC reference
20/NI/0085
Date of REC Opinion
8 Jul 2020
REC opinion
Further Information Favourable Opinion