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

PLOS ONE RESEARCH ARTICLE Stillbirth rates, service outcomes and costs of implementing NHS England’s Saving Babies’ Lives care bundle in maternity units in England: A cohort study Kate Widdows1, Stephen A. Roberts2, Elizabeth M. Camacho ID3, Alexander E. P. Heazell ID1,4* a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 1 Faculty of Biological, Medical and Health, Maternal and Fetal Health Research Centre, School of Medical Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, 2 Centre for Biostatistics, School of Health Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, 3 Manchester Centre for Health Economics, School of Health Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom, 4 St. Mary’s Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom * OPEN ACCESS Citation: Widdows K, Roberts SA, Camacho EM, Heazell AEP (2021) Stillbirth rates, service outcomes and costs of implementing NHS England’s Saving Babies’ Lives care bundle in maternity units in England: A cohort study. PLoS ONE 16(4): e0250150. https://doi.org/10.1371/ journal.pone.0250150 Editor: Ju Lee Oei, University of New South Wales, AUSTRALIA Received: August 4, 2020 Accepted: April 1, 2021 Published: April 19, 2021 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: https://doi.org/10.1371/journal.pone.0250150 Copyright: © 2021 Widdows et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: There is no ethical approval in place to share data from participating Trusts. Anonymised data from staff and patient Abstract 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 PLOS ONE | https://doi.org/10.1371/journal.pone.0250150 April 19, 2021 1 / 16 PLOS ONE Effect of implementing Saving Babies’ Lives care bundle on stillbirth rates in England questionnaires can be made available subject to appropriate confidentiality agreements between participating organisations. Investigators wishing to obtain data should initially contact the Edgbaston Research Ethics Committee (). 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. Funding: AH, EC and SR recieved funding for this work from NHS England. NHS England approved the research protocol but had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. 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. Competing interests: The authors have declared that no competing interests exist. Conclusions Trial registration The study was registered on (NCT03231007); www.clinicaltrials.gov. Introduction Stillbirth, defined in the UK as the death of a baby before birth after 24 weeks’ gestation [1], has been challenging to reduce, with an annual rate of reduction in the UK of 1.4% between 2000 and 2015, placing the UK in the lowest third of high-income countries (HICs) [2]. Analysis of stillbirth rates within the UK demonstrates significant variation between regions, with the highest stillbirth rates seen in some areas of London, Midlands and the North of England [3,4]. The variation between countries and within the UK suggests that improvement in the stillbirth rate is possible [2]. Given the significant psychological, social and economic impact of stillbirth on mothers and their families [5], further reduction in stillbirth rate in the UK is needed. Evidence suggests that a significant proportion of these deaths are preventable; Confidential Enquiries into normally formed antepartum stillbirths identified deficiencies in care that contributed to this outcome in 60% of cases, rising to 80% in intrapartum-related deaths [6,7]. Risk factors for stillbirth in HICs include: fetal growth restriction, maternal medical co-morbidities (e.g. diabetes, hypertension), cigarette smoking and maternal perception of reduced fetal movements [8]. Deficiencies in the identification and management of these risk factors has been reported in analyses of stillbirths dating back to 1998 [9]. This information provides a starting point for initiatives to reduce stillbirth in the UK. To address stillbirth rates in the UK, the Department of Health announced a new ambition to halve the rate of stillbirths by 2030, with a 20% reduction by 2020. In response, NHS England introduced the Saving Babies Lives (SBL) care bundle in 2015 which sought to implement recommendations from established national guidance to address specific risk factors for stillbirth, including i) smoking cessation, ii) fetal growth restriction, (...truncated)