Influences on patient safety in intrapartum electronic fetal heart rate monitoring with cardiotocography (iSafe): protocol for a systematic scoping review

Intrapartum electronic fetal monitoring (EFM) using cardiotocography (CTG) is the recommended method for monitoring the fetal heart rate during labour for high-risk births in England. An abnormal CTG indicates the need for further review and management including potential urgent intervention (e.g. expediting birth) to minimise risk of serious long-term harm to the baby or stillbirth. In the UK, as other European countries, sub-optimal intrapartum EFM management is implicated in a large share of cerebral palsy, birth asphyxia, peripartum hypoxic brain injuries and obstetric malpractice claims. In addition to the psychosocial and social impact of stillbirth or life-long disability on parents and babies, obstetric brain injury is costly, potentially resulting in settlements for millions of pounds to support families over a lifetime of care. Every baby born in the NHS in England now incurs indemnity costs of £1,100. Of the total Clinical Negligence Scheme for Trusts provision of £78bn, 70% relates to maternity. Though maternity claims made up just 10% of the number of clinical negligence claims received by NHS Resolution in 2018-19, they accounted for 50% of the total value of claims. The need for action to improve safety of intrapartum EFM is now urgent, but questions remain about how it can best be achieved. We propose that reducing avoidable harm linked to intrapartum EFM requires sound understanding of the influences on sub-optimal practice. A perhaps more fruitful approach than one that focuses solely on CTG interpretation, more technology and/or solely on training, is to look more broadly at influences on safety. Such an approach would be consistent with the literature in patient safety that has advocated a systems approach to understanding and addressing the effects and interactions of real-world contexts such as teamwork, tasks, equipment, workspace, culture and organisation on clinical performance. It is also consistent with a well-established definition of safety as an attribute of health systems. This systematic scoping review aims to identify what is known in the published literature about such influences on patient safety in intrapartum electronic fetal heart rate monitoring with cardiotocography.This work is part of THIS Institute’s research programme and is funded by the Health Foundation’s grant for THIS Institute to the University of Cambridge. The Health Foundation is an independent charity committed to bringing about better health and health care for people in the UK. The Health Foundation have had no involvement in the development of this protocol