Decision-support for individualised risk assessment of fetal health during labour: preventing fetal brain damage and death by utilising large, routinely collected datasets of cardiotocography and clinical risk factors

Our overarching goal is to improve clinical decision-making around labour management and cardiotocography (CTG) monitoring by providing timely, data-driven and individualised assessment of fetal wellbeing, so that fetal damage due to oxygen deprivation intrapartum can be avoided.

We have already developed a prototype Oxford System (OxSys) for continuous risk assessment throughout labour, running at the Oxford maternity ward (research only).

It is based on combined evaluation of clinical risk factors and CTG data (captured wirelessly in real-time from hospital fetal monitors) and is displayed on a prototype tablet/mobile App.

The aim of this proposal is to produce an independently validated, trustworthy and clinically relevant OxSys3.0, that is fully scalable and ready for commercialisation.

We have formed a multidisciplinary team of experts in obstetrics, neonatology, maternity and CTG data, computer science, signal processing, Deep Learning (DL), statistical prediction models, qualitative research, and health economics.

We propose Technical, Clinical and Commercial work-packages to: Enhance CTG information extraction using DL; Develop the App s technical capabilities incorporating relevant regularity requirements; Finalise OxSys3.0 for continuous risk assessment and validate it independently with external data; Ensure OxSys3.0 benefits midwives/obstetricians and mothers/families by understanding their needs/requirements, iterative App co-design, and formal usability studies; Test OxSys3.0 in a pilot prospective study to provide feasibility data; Develop NHS adoption strategy and early health economic model.

The Public and Patient Involvement and Advisory Panels will be central in ensuring that: work is relevant to all stakeholders; diverse viewpoints and voices are incorporated throughout; developments/results reach the widest possible audience.

At completion, we will also have: designed large-scale clinical effectiveness studies with funding applications submitted or in preparation; licensed-out OxSys3.0 to commercial partners or formed a dedicated company.

This project will maximise the likelihood of OxSys3.0 for clinical impact, benefitting individuals, society, and clinicians, and bringing considerable cost-savings to the NHS.