Every year, 25,000 pregnant women in the UK develop pre-eclampsia, 3,000 babies are stillborn, and 60,000 are born preterm. These numbers vary widely between hospitals, suggesting that some units manage risk better than others. This trial tests whether a single tool—the Tommy’s App—can close that gap. The app uses AI to give each woman a personalised risk score for placental disorders, then directs her to the right treatment. The study will roll it out across multiple NHS maternity units, comparing outcomes against standard care. If it works, the app could reduce rates of pre-eclampsia, preterm birth, and stillbirth nationwide. It would also tackle health inequalities by ensuring that women in under-resourced hospitals receive the same level of risk assessment as those in better-staffed units. The researchers will also assess whether women and clinicians find the app acceptable and whether it saves the NHS money. The ultimate goal is to make the UK the safest place in the world to give birth.
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There are 25,000 cases of pre-eclampsia, 3000 stillbirths and 60,000 preterm births per year in the UK[1-3]. There is currently wide variation between hospitals in rates of placental disorders, stillbirth and preterm birth[4]. The Tommy’s App medical device uses clinically-validated AI-based algorithms to provide a more accurate and personalised pregnancy risk assessment for women during pregnancy allowing them to be allocated the correct targeted treatments, with the overarching aim of reducing pre-eclampsia, preterm birth and stillbirth, and reducing health inequalities. Aims & Objectives To evaluate the effect of the ‘real world’ implementation of the Tommy’s App device within the NHS. The following research objectives will facilitate achievement of this aim. Work plan and methods used Cluster randomised controlled trial to demonstrate improved pregnancy outcomes (effectiveness) with the use of Tommy’s App compared to standard care (Work Stream 1) A mixed methods process evaluation to determine whether the Tommy’s App is acceptable to both women and health care practitioners, and that it can be successfully adopted into routine clinical practice (Work Stream 2) Evaluating health economic data on the cost-effectiveness of implementing Tommy’s App into NHS maternity units (Work Stream 3) Timelines for delivery 6-month setup, 15-month recruitment, 9-month follow-up, 6-month report and closedown Anticipated impact and Dissemination Our aim is to make the UK the safest place in the world to give birth by improving women’s access to best care and reducing inequity in provision and quality of care. The Tommy’s App, if shown to be effective, will reduce rates of pre-eclampsia, preterm birth and stillbirth in maternity units across the UK. The Tommy’s National Centre for Maternity Improvement, led by the Royal Colleges and supported by Department of Health and Social Care, will lead on development of a roadmap for integration of Tommy’s App into maternity care pathways.
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