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

母体败血症--迫切需要研究“母体败血症”是孕期或孕期后感染引起的一种危及生命的疾病。如果身体对正在发展的感染的反应导致自身器官受损，就会发生这种情况。产妇败血症占所有产妇死亡的一半。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一努力的重要组成部分。然而，国际社会对这一问题的关注不足，迫切需要找到解决这一问题的有效方法。“积极预防和治疗产妇败血症”或APT-败血症是一项精心设计的方案，专门用于现有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，以确保母亲得到尽可能最好的护理，以更好地预防和管理感染。特别是，该方案将通过确保卫生保健工作者：1)始终洗手以防止感染的传播，2)通过遵循世界卫生组织关于孕期和分娩期间预防感染的所有指南来预防感染，从而改善护理。3)定期监测生命体征并迅速采取行动，确保使用专门开发的母体败血症治疗“捆绑”对疑似败血症的妇女进行所有正确的初步治疗。我们的方法有助于提供所需的信息、动力和工具。这包括现场提供的培训、基于纸张的清单和提醒、能够帮助鼓励变革并提供持续反馈和指导的现场领先者网络、现场管理的参与、重新组织员工之间的任务分担以及帮助激励现场和个人。我们多年来一直在与世界卫生组织和资源匮乏国家的医疗工作者合作，开发ATP-败血症。我们已经在多家医院测试了该方案的所有部分，结果表明，它改善了向妇女提供的护理质量，它是可以接受的，而且实践中的变化可以保持。然而，为了证明它可以改善最重要的结局，如妇女死亡或患有非常严重的感染，需要一项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-败血症试验要仔细回答APT-败血症计划是否减少母亲死亡或患有最严重感染的问题，将涉及临床试验。这项工作将在马拉维和乌干达进行。我们将在每个国家的30家医院开展工作。在对所有设施的结果进行仔细评估的一段时间后，一半的医院将测试APT-败血症干预措施，一半的医院将继续其惯常做法。哪些医院将使用APT-脓毒症将随机决定，但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-败血症的医院和那些发生常规做法的医院的结果。我们还将详细研究该方案的执行方式。这方面将包括衡量设施中正在发生的事情，并进行详细的访谈，以了解工作人员的意见。这项研究将告诉我们，APT-脓毒症计划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败血症死亡。它还将帮助我们了解APT-脓毒症是如何在研究地点使用的，以便我们可以计划进一步的实施，如果它被证明是有用的。我们还将发现APT-脓毒症计划是否具有成本效益。

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.