Improving uptake of delivery care services in rural Tanzania through demand creation, ambulance transport and quality of care: a feasibility study

这是一项关于为改善坦桑尼亚农村地区与怀孕和分娩相关的孕产妇和新生儿健康状况的综合干预措施的试行和可行性研究的建议。该干预措施旨在通过增加坦桑尼亚农村地区产前和分娩护理服务的普及来预防怀孕和分娩中的紧急情况。尽管2015年标志着千年发展目标时代的结束，但该区域在降低可避免的妊娠和分娩相关死亡率方面进展太慢，这有助于将孕产妇和新生儿健康纳入全球议程。迫切需要更多的研究来解决这一重要的公共卫生问题。不良分娩结局的高发生率在很大程度上可以归因于怀孕和分娩期间的一些常见并发症，如果有适当的产前和分娩护理，这些并发症原则上是可以避免或解决的。增加以设施为基础的接生护理的主要障碍是：(1)缺乏对在熟练助产士的帮助下接生的重要性的认识，(2)分娩妇女获得交通工具的机会有限，(3)许多卫生工作者接生技能陈旧的农村设施的接生护理质量不足，以及缺乏必要的设备和消耗品，我们的干预措施包括以下主要部分：(1)在社区开展宣传活动，提高妇女及其家人对由熟练助产士接生的重要性的认识(在非洲农村，只有卫生机构才能提供助产士)。(2)为就近的健康中心设立免费电话热线，以便在分娩开始时或在紧急情况下安排交通服务。(3)使用当地生产的低成本摩托车救护车拖车，免费将分娩妇女运送到最近的HC。(4)加强当地保健机构的基本助产技能，从而改善他们提供的保健服务的声誉。迄今为止，还没有证明可行的、具有成本效益的干预措施可以同时解决护理方面的每一个主要障碍，并改善“艰难”的妊娠结局。需要强有力的证据来证明可扩展的、负担得起的、具有持续效果的干预。主要试验中的最终评估将在一项整群随机试验中评估干预措施在改善孕产妇和新生儿健康结果方面的有效性和成本效益，该试验的群组包括农村保健中心及其服务的社区(病房)。拟议的早期研究需要加强干预，为其可行性提供证据，并使我们能够完善主要试验中评估的设计。这项早期研究的目标是：(-)进行形成性研究，为干预措施的设计提供支持，并提高潜在研究参与者对干预措施开发的参与度。(-)纳入形成研究阶段的意见，以确定干预措施的所有方面，并制定一套标准的操作程序和干预手册。(-)全面试行干预措施，以帮助识别和解决无法预见的挑战，促进操作研究，以评估干预措施的过程措施和干预措施所有个别方面的可行性。(-)获得干预措施可能在多大程度上成功地创造对以设施为基础的分娩护理的更多需求的初步指标。(-)建立和测试主要研究计划的调查技术的可行性。

This is a proposal for a trial development and feasibility study for a complex intervention to improve pregnancy- and birth-related maternal and neonatal health outcomes in rural Tanzania.The intervention aims to prevent emergencies in pregnancy and childbirth by increasing uptake of antenatal and delivery care services in rural Tanzania. Progress has been much too slow towards reducing the high rates of avoidable pregnancy- and birth-related deaths that persist in the region despite 2015 marking the end of the MDG era, which helped place maternal and newborn health on the global agenda. More research is urgently needed to address this important public health issue. The high rates of adverse birth outcomes can largely be attributed to a handful of common complications during pregnancy and labour which are in principle trivially avoided or resolved given adequate antenatal and delivery care. The central barriers to increased uptake of facility-based delivery care are, (1) a lack of awareness of the importance of delivering with assistance from skilled birth attendants, (2) limited access to transport for women in labour, and (3) inadequate quality of delivery care in rural facilities with outdated midwifery skills among many health workers and a lack of essential equipment and consumables, poor supervision structures and inadequate procedures for timely referral to larger facilities.Our intervention consists of the following main components: (1) Campaigning in the community to raise awareness among women and their families of the importance of delivering with skilled birth attendants (which in rural Africa is only available in health facilities). (2) A free-of-charge telephone hotline to the nearest Health Centre (HC) to arrange transport at onset of labour or in case of emergency. (3) Free-of-charge transport for women in labour to the nearest HC using locally produced low-cost motorcycle-drawn ambulance trailers. (4) Strengthening of essential midwifery skills in local HCs thus improving the reputation of the care they provide.To date no feasible, cost-effective intervention has been demonstrated to simultaneously address each of the major barriers to care and improve 'hard' pregnancy outcomes. Robust evidence is needed of a scalable, affordable intervention with a sustained effect. The definitive evaluation in a main trial will estimate effectiveness and cost-effectiveness of the intervention in improving maternal and neonatal health outcomes in a cluster randomised trial with clusters comprising rural HCs and the communities (wards) they serve. The proposed early-phase study is required to strengthen the intervention, generate evidence on its feasibility, and allow us to perfect the design of the evaluation in the main trial. The objectives of this early phase study are:(-) to conduct formative research to feed into the design of the intervention, and to improve participation from potential study participants in the development of the intervention. (-)incorporating observations from the formative research phase, to finalise all aspects of the intervention components and produce a set of standard operating procedures and intervention manuals.(-) to pilot the intervention in its entirety which will help identify and resolve unforeseen challenges, facilitate operational research to evaluate process measures and feasibility of all individual aspects of the intervention.(-)to obtain preliminary indicators as to how successful the intervention is likely to be in creating increased demand for facility-based delivery care.(-)to establish and test the feasibility of survey techniques planned for the main study.