Department of Research, Haydom Lutheran Hospital, Haydom, Manyara, Tanzania.
School of Public Health and Social Sciences, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.
BMC Health Serv Res. 2021 Oct 18;21(1):1117. doi: 10.1186/s12913-021-07145-1.
The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middle-income countries, especially around the time of birth. There are scarce resources and/or support implementation of evidence-based training programs. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival.
The project will follow a stepped-wedge cluster implementation design with well-established infrastructures for data collection, management, and analysis in 30 public health facilities in regions in Tanzania. Healthcare workers from selected health facilities will be trained in basic neonatal resuscitation, essential newborn care and essential maternal care. Foetal heart rate monitors (Moyo), neonatal heart rate monitors (NeoBeat) and skills trainers (NeoNatalie Live) will be introduced in the health facilities to facilitate timely identification of foetal distress during labour and improve neonatal resuscitation, respectively. Heart rate signal-data will be automatically collected by Moyo and NeoBeat, and newborn resuscitation training by NeoNatalie Live. Given an average of 4000 baby-mother pairs per year per health facility giving an estimate of 240,000 baby-mother pairs for a 2-years duration, 25% reduction in perinatal mortality at a two-sided significance level of 5%, intracluster correlation coefficient (ICC) to be 0.0013, the study power stands at 0.99.
Previous reports from small-scale Safer Births Bundle implementation studies show satisfactory uptake of interventions with significant improvements in quality of care and lives saved. Better equipped and trained birth attendants are more confident and skilled in providing care. Additionally, local data-driven feedback has shown to drive continuous quality of care improvement initiatives, which is essential to increase perinatal and maternal survival. Strengths of this research project include integration of innovative tools with existing national guidelines, local data-driven decision-making and training. Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope.
Name of Trial Registry: ISRCTN Registry.
ISRCTN30541755 . Date of Registration: 12/10/2020. Type of registration: Prospectively Registered.
在中低收入国家，死产、新生儿和孕产妇死亡的负担高得令人无法接受，尤其是在分娩期间。资源稀缺，或无法支持实施基于证据的培训计划。SafeBirths 护理包是一整套经过充分验证的创新工具，结合了数据驱动的在职培训，旨在降低围产期和孕产妇死亡。本项目旨在确定扩大护理包对改善分娩期护理质量和围产儿生存的影响。
该项目将采用逐步楔形集群实施设计，在坦桑尼亚 30 个公共卫生设施中建立了完善的基础设施，用于数据收集、管理和分析。从选定的卫生设施中选择医护人员进行基础新生儿复苏、基本新生儿护理和基本产妇护理培训。胎儿心率监测仪（Moyo）、新生儿心率监测仪（NeoBeat）和技能培训器（NeoNatalie Live）将引入卫生设施，以便在分娩期间及时识别胎儿窘迫，并分别提高新生儿复苏能力。Moyo 和 NeoBeat 将自动收集心率信号数据，NeoNatalie Live 将进行新生儿复苏培训。鉴于每个卫生设施每年平均有 4000 对母婴，为期 2 年的估计值为 240000 对母婴，假设围产期死亡率降低 25%，双侧显著性水平为 5%，簇内相关系数（ICC）为 0.0013，研究的效力为 0.99。
之前小规模的 SafeBirths 护理包实施研究报告显示，干预措施的接受度令人满意，护理质量和挽救的生命均有显著改善。装备更好、培训更有素的接生员更有信心、更有技能提供护理。此外，基于当地数据的反馈表明，这有助于推动持续的护理质量改进举措，这对于提高围产儿和孕产妇的生存率至关重要。本研究项目的优势包括将创新工具与现有国家指南相结合，以及基于当地数据的决策和培训。局限性包括逐步集群实施设计可能导致干预措施的污染，以及/或者无法解决项目范围之外的医护人员短缺和医疗用品短缺问题。
试验注册名称：ISRCTN 注册表。
ISRCTN30541755。注册日期：2020 年 10 月 12 日。注册类型：前瞻性注册。
