Stillbirth rates, service outcomes and costs of implementing NHS England’s Saving Babies’ Lives care bundle in maternity units in England: A cohort study

OBJECTIVE: To assess implementation of the Saving Babies Lives (SBL) Care Bundle, a collection of practice recommendations in four key areas, to reduce stillbirth in England. DESIGN: A retrospective cohort study of 463,630 births in 19 NHS Trusts in England using routinely collected electronic data supplemented with case note audit (n = 1,658), and surveys of service users (n = 2,085) and health care professionals (n = 1,064). The primary outcome was stillbirth rate. Outcome rates two years before and after the nominal SBL implementation date were derived as a measure of change over the implementation period. Data were collected on secondary outcomes and process outcomes which reflected implementation of the SBL care bundle. RESULTS: The total stillbirth rate, declined from 4.2 to 3.4 per 1,000 births between the two time points (adjusted Relative Risk (aRR) 0.80, 95% Confidence Interval (95% CI) 0.70 to 0.91, P<0.001). There was a contemporaneous increase in induction of labour (aRR 1.20 (95%CI 1.18–1.21), p<0.001) and emergency Caesarean section (aRR 1.10 (95%CI 1.07–1.12), p<0.001). The number of ultrasound scans performed (aRR 1.25 (95%CI 1.21–1.28), p<0.001) and the proportion of small for gestational age infants detected (aRR 1.59 (95%CI 1.32–1.92), p<0.001) also increased. Organisations reporting higher levels of implementation had improvements in process measures in all elements of the care bundle. An economic analysis estimated the cost of implementing the care bundle at ~£140 per birth. However, neither the costs nor changes in outcomes could be definitively attributed to implementation of the SBL care bundle. CONCLUSIONS: Implementation of the SBL care bundle increased over time in the majority of sites. Implementation was associated with improvements in process outcomes. The reduction in stillbirth rates in participating sites exceeded that reported nationally in the same timeframe. The intervention should be refined to identify women who are most likely to benefit and minimise unwarranted intervention. TRIAL REGISTRATION: The study was registered on (NCT03231007); www.clinicaltrials.gov.