Completed Pregnancy, Children & Inherited Conditions Diabetes, Hormones & Metabolism

Novel Biomarker Test with Treatment, to Predict and Prevent Miscarriage and Adverse Birth Outcomes in Ethnically Diverse Patient Populations.

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A prototype blood test is being manufactured and trialled to predict and prevent miscarriages and other adverse birth outcomes, with a specific focus on Black and Asian patients who face higher risks. This matters because miscarriage and complications like preterm birth affect thousands of pregnancies each year, yet current prediction tools are limited and often fail to account for ethnic differences in risk. The project builds on earlier feasibility work to produce a final-format diagnostic test, then validate it in a randomised controlled trial. An economic analysis will assess the test’s value to the NHS by calculating savings from fewer miscarriages and reduced long-term costs of adverse outcomes. If successful, the test could become a routine part of antenatal care, allowing early identification of high-risk pregnancies and targeted treatment. This would reduce preventable harm to mothers and children, and lower healthcare costs. The project also includes documentation needed for regulatory clearance, moving the test toward clinical use. For a funder focused on maternity outcomes, this work directly addresses a persistent gap in equitable, evidence-based care.

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The project builds on earlier Innovate funded feasibility work and comprises manufacturing a prototype test for validation and stability testing, for an eventual manufactured form of a novel test for adverse pregnancy outcomes affecting mothers and children. This will include Black and Asian ethnicity patients who are at higher risk of these adverse outcomes The project will include utilising the final format test in a robust Randomised Control Trial, evaluating clinical significance of testing and treating patients to reduce adverse birth outcomes. It will also include an economic analysis to determine the monetary impact of introducing the test into the NHS to establish the economic value in terms of: reduced miscarriage (short-term costs), and longer term costs reduced by reducing adverse birth outcomes and their societal costs The project includes the documentation and documented processes to obtain regulatory clearance for the test in final format.

View the original record at the funder ↗

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