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.
Centre for Biostatistics, School of Health Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.
PLoS One. 2021 Apr 19;16(4):e0250150. doi: 10.1371/journal.pone.0250150. eCollection 2021.
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.
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.
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.
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.
The study was registered on (NCT03231007); www.clinicaltrials.gov.
评估 Saving Babies Lives（SBL）护理包的实施情况，该护理包包含四个关键领域的实践建议，旨在减少英格兰的死产。
这是一项回顾性队列研究，纳入了英格兰 19 家 NHS 信托机构的 463630 例分娩，使用常规收集的电子数据进行补充，并进行了病例记录审核（n=1658）、服务使用者调查（n=2085）和卫生保健专业人员调查（n=1064）。主要结局是死产率。在名义 SBL 实施日期前后两年的结局率被作为实施期间变化的衡量标准。收集了反映 SBL 护理包实施的次要结局和过程结局的数据。
总死产率从两个时间点的每 1000 例活产 4.2 例降至 3.4 例（调整后的相对风险（aRR）0.80，95%置信区间（95%CI）0.70 至 0.91，P<0.001）。同期，引产（aRR 1.20（95%CI 1.18-1.21），p<0.001）和紧急剖宫产（aRR 1.10（95%CI 1.07-1.12），p<0.001）的比例增加。进行的超声检查次数（aRR 1.25（95%CI 1.21-1.28），p<0.001）和检测到的小于胎龄儿比例（aRR 1.59（95%CI 1.32-1.92），p<0.001）也有所增加。报告实施水平较高的组织在护理包所有元素的过程措施方面均有改善。一项经济分析估计，实施护理包的成本约为每例分娩 140 英镑。然而，成本的变化以及结果的变化都不能明确归因于 SBL 护理包的实施。
SBL 护理包的实施在大多数地点随着时间的推移而增加。实施与过程结局的改善相关。参与地点的死产率下降幅度超过了同期全国报告的水平。该干预措施应加以改进，以确定最有可能受益的妇女，并尽量减少不必要的干预。
该研究于（NCT03231007）注册；www.clinicaltrials.gov。
