PDF(Pubmed)
Abstract：
BACKGROUND: The CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways.
METHODS: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken.
CONCLUSIONS: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes.
BACKGROUND: ISRCTN 94429427. Registered on 20 April 2022.
METHODS: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken.
CONCLUSIONS: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes.
BACKGROUND: ISRCTN 94429427. Registered on 20 April 2022.
摘要：
背景：Cradle生命体征警报干预（一种精确的易于使用的设备，通过内置的交通灯预警系统测量血压和脉搏，和重点培训包）在塞拉利昂城市地区进行试验时，与降低子痫和孕产妇死亡率有关。随后，实施得到了成功的试点，忠诚的措施证明了这一点，可行性和采用。CRADLE-5试验将检查国家扩大规模，包括大部分农村地区,将降低孕产妇和胎儿死亡率和孕产妇发病率的复合结局，并将评估如何将CRADLE软件包可持续地嵌入常规临床路径中。
方法：CRADLE-5是一项针对CRADLE干预的阶梯式楔形集群随机对照试验，与塞拉利昂八个农村地区的常规产妇护理相比（Bonthe，法拉巴,Karene,凯拉洪,Koinadugu,Kono,莫扬巴,Tonkolili）。每个地区将在1年内（2022年5月至2023年6月）以六周的间隔从控制到干预。包括所有确定为孕妇或产后六周内接受该地区产妇护理的妇女。主要结局数据(孕产妇死亡的综合比率，死产,子痫和紧急子宫切除术）将被收集。混合方法过程和扩大评估（由医学研究理事会关于复杂干预措施的指南和世界卫生组织ExpandNet工具提供指导）将探讨保真度的实施结果，收养,适应和扩大覆盖范围的结果，维护,可持续性和一体化。将评估变化机制和环境因素（障碍和促进因素）。将同时进行成本效益分析。
结论：国际指南建议所有孕妇和产后妇女定期进行血压评估，和医护人员充分的培训，以应对异常。在更多农村地区改善孕产妇和围产期健康的临床效果，规模干预的整合和可持续性的难易程度尚待研究。该试验将探讨全国范围扩大CRADLE干预措施是否能降低孕产妇和胎儿死亡率以及严重的孕产妇不良结局，并了解采用策略。在低资源环境中的整合和可持续性。如果成功,目的是发展一种适应性强的，基于证据的扩大路线图，以改善母婴结局。
背景：ISRCTN94429427。2022年4月20日注册。
方法：CRADLE-5是一项针对CRADLE干预的阶梯式楔形集群随机对照试验，与塞拉利昂八个农村地区的常规产妇护理相比（Bonthe，法拉巴,Karene,凯拉洪,Koinadugu,Kono,莫扬巴,Tonkolili）。每个地区将在1年内（2022年5月至2023年6月）以六周的间隔从控制到干预。包括所有确定为孕妇或产后六周内接受该地区产妇护理的妇女。主要结局数据(孕产妇死亡的综合比率，死产,子痫和紧急子宫切除术）将被收集。混合方法过程和扩大评估（由医学研究理事会关于复杂干预措施的指南和世界卫生组织ExpandNet工具提供指导）将探讨保真度的实施结果，收养,适应和扩大覆盖范围的结果，维护,可持续性和一体化。将评估变化机制和环境因素（障碍和促进因素）。将同时进行成本效益分析。
结论：国际指南建议所有孕妇和产后妇女定期进行血压评估，和医护人员充分的培训，以应对异常。在更多农村地区改善孕产妇和围产期健康的临床效果，规模干预的整合和可持续性的难易程度尚待研究。该试验将探讨全国范围扩大CRADLE干预措施是否能降低孕产妇和胎儿死亡率以及严重的孕产妇不良结局，并了解采用策略。在低资源环境中的整合和可持续性。如果成功,目的是发展一种适应性强的，基于证据的扩大路线图，以改善母婴结局。
背景：ISRCTN94429427。2022年4月20日注册。
