The Salurate Study.
Research type
Research Study
Full title
Validation of salivary uric monitoring for early prediction of hypertensive disorders of pregnancy.
IRAS ID
337290
Contact name
Baskaran Thilaganathan
Contact email
Sponsor organisation
Morgan Innovation & Technology Ltd.
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 10 months, 26 days
Research summary
Over 10% of pregnant women experience high blood pressure and related conditions such as pre-eclampsia (PE). Untreated PE is the second biggest cause of maternal deaths - 63,000 annually worldwide. Despite this, there is currently no way of accurately predicting who may develop PE. The NHS incurs avoidable costs from monitoring pregnant women who are wrongly assigned as having a high-risk pregnancy, emergency interventions on women with undiagnosed PE and paying compensation when mothers or babies suffer due to undiagnosed hypertensive disorders.
This project builds upon research that has shown that measuring the concentration of a chemical called uric acid in saliva (SUA) can predict which expectant mother will develop hypertension. Over the last ten years the Sponsor has:
*Developed chemistry so that SUA causes a measurable colour change on a test paper, proportional to its concentration
*Developed a saliva sampling device
*Developed technology to relate colour change to SUA concentration
*Related SUA concentration to how likely it is that a pregnant woman will develop hypertensive disorders
We call this novel technology Salurate.We propose that Salurate can identify women who are likely to develop hypertensive disease more accurately than current clinical protocol with a non-invasive test that women can use at home. By identifying women more accurately, and earlier, women who really need it can get the targeted treatment they require.
The study aims to recruit women from two NHS trusts who, at their booking ultrasound scan, are deemed to be at medium or high risk of developing hypertensive disease in pregnancy according to the ASPRE algorithm. They will be asked to perform weekly home salivary uric acid testing until the conclusion of their pregnancy. The results from these tests will be analysed alongside the outcomes of the pregnancy by the study team. The participants will not have access to the results, and the study team are blinded to participants. The results of the Salurate test will not affect or alter clinical care.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0123
Date of REC Opinion
5 Jul 2024
REC opinion
Further Information Favourable Opinion