An International Collaboration to Implement and Evaluate at Scale the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis Programme)

孕产妇败血症-一个迫切的研究需要“孕产妇败血症”是一种危及生命的条件所造成的感染期间或之后怀孕。如果身体对发展中的感染的反应导致自身器官受损，就会发生这种情况。孕产妇败血症占孕产妇死亡总数的一半。在国际上，世界卫生组织和联合国等组织致力于减少因怀孕和分娩而死亡的妇女人数。解决产妇败血症是这项工作的重要组成部分。然而，国际上对这一问题的关注还不够，迫切需要找到解决这一问题的有效方法。一个潜在的解决方案“积极预防和治疗孕产妇败血症”或APT-败血症是一个精心制定的计划，专门用于资源有限的国家和设施。它旨在改变卫生保健工作者的行为，以确保母亲获得尽可能好的护理，以更好地预防和管理感染。特别是，该方案将通过确保保健工作者：1）经常洗手，以防止感染的传播，2）遵循世界卫生组织关于预防怀孕和分娩期间感染的所有指南，预防感染3）定期进行生命体征监测并迅速采取行动，确保疑似败血症的女性使用特殊的药物获得所有正确的初步治疗制定了孕产妇败血症治疗“一揽子计划”。该计划基于这样一种认识，即改变保健工作者的行为需要采取精心规划的方法。我们的方法有助于提供所需的信息、动力和工具。这包括在现场提供的培训、基于纸张的检查表和提醒、可以帮助鼓励变革并提供持续反馈和指导的现场支持者网络、现场管理人员的参与，重新表示组织员工之间的任务分担，帮助激励研究中心和个人。为试验做准备我们已经与世界卫生组织和低资源国家的医疗保健工作者合作了几年导致ATP败血症我们在多家医院对该方案的各个部分进行了测试，结果表明，该方案提高了妇女护理的质量，是可以接受的，实践中的变化可以保持下去。然而，要证明它改善了最重要的结果，如妇女死亡或患有非常严重的感染，需要一个涉及许多中心和妇女的大型试验，这就是我们现在计划做的。APT-脓毒症试验为了仔细回答这个问题，如果APT-脓毒症方案减少母亲死亡或患有最严重的感染，将涉及临床试验。我们将在马拉维和乌干达开展这项工作，并将在每个国家的30家医院开展工作。经过一段时间，所有设施的结果将被仔细衡量，一半的医院将测试APT败血症干预，一半将继续他们的常规做法。哪些医院将使用APT-脓毒症将由偶然决定，但要确保两组之间的设施平衡。在接下来的20个月里，我们将比较那些参与APT-脓毒症治疗的医院和那些常规治疗的医院的结果。我们还将详细研究该方案的执行情况。这方面将涉及测量设施中发生的情况，以及详细的访谈，以了解工作人员的意见。这项研究将告诉我们，APT脓毒症项目是否可以减少不良后果，并在资源不足的情况下阻止孕产妇脓毒症死亡。它还将帮助我们了解APT-脓毒症是如何在研究中心使用的，以便我们可以计划进一步实施，如果它被证明是有用的。我们还将发现APT败血症方案是否具有成本效益。

MATERNAL SEPSIS - AN URGENT RESEARCH NEED"Maternal sepsis" is a life threatening condition caused by infection during or after pregnancy. It occurs if the body's response to a developing infection causes damage to its own organs. Maternal sepsis contributes to half of all maternal deaths. Internationally, organisations such as the World Health Organisation and United Nations are committed to reducing the numbers of women who die due to pregnancy and childbirth. Tackling maternal sepsis is an important part of this effort. However, there has been inadequate international focus on this issue, and there is an urgent need to identify effective ways to combat this problem.A POTENTIAL SOLUTION"The Active Prevention and Treatment of Maternal Sepsis" or APT-sepsis is a carefully developed programme designed specifically to be used in countries and facilities where there are limited resources available. It aims to change health care workers behaviours to ensure mothers get the best care possible to better prevent and manage infections. In particular the programme will improve care by ensuring that health care workers: 1) always wash their hands to prevent the transmission of infections, 2) prevent infections by following all the World Health Organisation guidelines on infection prevention during pregnancy and birth 3) carry out regular vital sign monitoring and act rapidly to ensure women with suspected sepsis are given all the correct initial treatments using a specially developed maternal sepsis treatment "bundle".This programme is based on an understanding that changing behaviours of health care workers required a carefully planned approach. Our approach helps provide the information, motivation and tools needed. This includes training delivered at the site, paper based checklists and reminders, a network of site champions who can help encourage change and provide ongoing feedback and coaching, involvement of the site management, re-organising sharing of tasks between staff and helping motivate sites and individuals.WORK PREPARING FOR THE TRIALWe have been working over several years with the World Health Organisation and healthcare workers in low resource countries to develop ATP-sepsis. We have tested all parts of the programme in multiple hospitals and shown that it improves the quality of care given to women, and that it is acceptable and that change in practice can be maintained. However, to show that it improves the most important outcomes such as women dying or having very severe infections needs a large trial involving many centres and women and this is what we now plan to do.THE APT-SEPSIS TRIALTo carefully answer the question if the APT-sepsis programme reduces mothers dying or having the most severe infections will involve a clinical trial. This will be done in Malawi and Uganda.We will work across 30 hospitals in each country. After a period where the outcomes will be carefully measured across all facilities, half of the hospitals will then test the APT-sepsis intervention and half will continue their usual practices. Which hospitals will use APT-sepsis will be decided by chance, but making sure that there is a balance in the facilities between both groups.For the next 20 months we will then compare the outcomes in those hospitals taking part in APT-sepsis and those where usual practice is occurring. We will also look in detail at the way the programme is being carried out. This aspect will involve measuring what is happening at the facilities and also detailed interviews to understand the opinions of staff.This research will tell us if the APT-sepsis programme can reduce bad outcomes and stop deaths from maternal sepsis in low resource settings. It will also help us understand how APT-sepsis is used in the study sites so that we can plan further implementation if it is shown to be useful. We also will discover if the APT-sepsis programme is cost effective.