Overall summary
Fit4Labour is a clinical decision support tool for safer births which predicts how a baby will cope with contractions during labour leading to the right intervention at the right time. It is designed for midwives/obstetricians to use at the onset of labour to improve intrapartum fetal monitoring and identify babies at risk of hypoxic injury. Health Innovation Oxford and Thames Valley (HIOTV) carried out a barrier to adoption study and gained insights from frontline clinicians to evaluate the clinical utility of Fit4Labour in the labour management pathway. Many stakeholders felt that the technology has the potential to improve overall fetal outcomes. HIOTV is now focusing on cost-effectiveness. Further clinical studies are required prior to regulatory approval, and to generate evidence for adoption by the NHS.
What is the challenge?
Labour is currently monitored by cardiotocography (CTG), a belt producing a continuous electronic graph which displays the fetal heart rate and womb contractions. Despite interventions to improve CTG interpretation and staff training, it has been identified as one of the most common causes of avoidable harm in maternity care due to problems with signalling, subjectivity and misreading. Obstetric litigation is on the increase, and reviews into litigation cases reveal that most claims relating to the intrapartum period are due to misinterpretation or incorrect action of CTGs in the presence of fetal heart rate abnormalities. In the UK each year, about 1,200 babies sustain brain damage during labour at term. Claims relating to cerebral palsy, and hypoxic brain injuries involve substantial and uncapped settlements. Obstetric care covers 26% of the NHS workload, but it accounts for more than 60% of the NHS’s litigation bill.
What did we do?
Health Innovation Oxford and Thames Valley conducted a barrier to adoption study to investigate the potential utility and barriers to adoption for the Fit4Labour test for use in labour management. A literature review was performed to map the labour care pathway and a visual representation of the care pathway was created, with and without the Fit4Labour test. Clinical stakeholders, largely comprising midwives and obstetricians involved in the pathway, were also interviewed to explore the potential clinical utility of the Fit4Labour test in labour management in England.
What has been achieved?
Stakeholders agreed that implementing the Fit4Labour test could improve the care pathway by reducing subjectivity in CTG trace interpretation and lead to more effective decision-making and better clinical outcomes for babies and mothers. They also said that the test would prompt clinicians to insert individual risk factors which would help to ensure that none were missed or forgotten when assessing patients. The stakeholders identified potential barriers to adoption – this feedback is crucial for the technology to be developed in a way that would increase the likelihood of future adoption by the NHS.
What people said
“We found working with the Oxford AHSN very useful, because their team has been very engaged. We had multiple stimulating discussions along the process, which really helped shape our understanding of the clinical pathways, informing the way we are developing our decision support tool. The written report provides an excellent resource, which can be easily shared with stakeholders as we move towards clinical implementation.”
Professor Antoniya Georgieva, Group lead – Oxford Labour Monitoring, University of Oxford.
What next?
Health Innovation Oxford and Thames Valley is now working on willingness-to-pay and cost-effectiveness analysis including stakeholder feedback to develop pricing strategies aligned with National Institute for Health and Care Excellence (NICE) thresholds. Further clinical studies are required to allow the technology to gain regulatory approval, and to generate evidence supporting adoption by the NHS.
Contact
Mamta Bajre, Lead Health Economist & Methodologist, Health Innovation Oxford and Thames Valley mamta.bajre@healthinnovationoxford.org