Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study and feasibility assessment

“产妇败血症”是由妊娠或分娩期间或之后的感染引起的医学问题。当身体对感染的反应开始对自身器官和组织造成损害时，就会发生这种情况。如果在发病后不及时发现和治疗，可能会危及生命。事实上，在世界范围内，它是与怀孕和分娩有关的第三大常见死亡原因。在国际上，世界卫生组织和联合国等组织致力于减少妇女死于与怀孕有关的可预防原因的人数。应对孕产妇败血症是这一努力的重要组成部分。在高收入国家，研究表明，同时给予若干组关键治疗有助于减少败血症的不良后果和死亡。这些治疗组有时被称为“治疗包”。由于这项研究，以及在全球范围内解决孕产妇败血症的重要性，专门针对孕产妇败血症开发了一种治疗方案。这种治疗组合被称为FAST-M，是为在资源贫乏的环境中使用而开发的，并在许多设施中进行了测试，因此我们知道它可以用于改善护理。我们团队想要回答的下一个重要研究问题是，应该从哪些女性开始进行FAST-M治疗。在高收入环境和一般成年人群中，通常使用血液检查来帮助判断哪些患者因败血症而最不适，哪些患者有不良预后的风险。这种血液测试测量血液中一种叫做乳酸的酸，这是一种很有帮助的测试，可以确定哪些人需要最紧急的治疗。现在可以使用小型手持机器来测量乳酸盐，这意味着即使在没有适当实验室设施的地方也可以使用它。然而，目前尚不清楚怀孕或刚怀孕的成人感染时乳酸发生了什么变化，也不知道在资源匮乏的环境中使用该测试是否有效。怀孕和分娩前后身体的变化会改变身体对感染的反应，这也可能改变测试的效果。我们的研究小组想要弄清楚，在识别最有可能患有母体败血症并遭受不良后果的妇女时，使用快速乳酸试验是否比常规观察更好。我们打算在3个国家进行这项研究；马拉维，巴基斯坦和乌干达。我们将在医院内查明产妇感染病例。在得到这些妇女的同意后，我们将增加抽取血液样本进行乳酸测试。我们不会改变通常的治疗方法，而是关注这些妇女的情况，直到她们出院。我们将看看乳酸试验的结果，与通常的观察结果相比较，看看它在诊断产妇败血症和预测不良结果方面的比较。在研究的第二部分，我们想知道在低资源环境下，是否可以使用这种乳酸测试作为孕产妇败血症护理的一部分，并与FAST-M捆绑治疗相结合，以及是什么使其更容易或更困难。为了做到这一点，我们将使用乌干达和巴基斯坦的站点，看看乳酸盐测试在使用时是如何工作的。我们将通过测量患者的情况，以及是否正确可靠地使用它，仔细研究工作人员如何使用它。我们还将向工作人员发放问卷，并与医疗工作者和设施内的其他人详细交谈，以了解他们对测试的看法。这项研究将帮助我们了解使用乳酸血测试是否有助于诊断产妇败血症病例，以及如何在资源有限的设施中使用该测试来改善护理。我们希望这一信息将有助于减少全世界孕产妇败血症病例的死亡和不良后果。

"Maternal sepsis" is a medical problem caused by infection during or after pregnancy or childbirth. It occurs when the body's response to infection starts to cause damage to its own organs and tissues. It can be life-threatening if not identified and treated quickly after it has developed. In fact, worldwide it is the 3rd most common cause of death related to pregnancy and childbirth. Internationally, organisations such as the World Health Organisation and United Nations are committed to reducing the numbers of women who die from preventable causes related to their pregnancies. Tackling maternal sepsis is an important part of this effort.In high income countries research has shown that groups of key treatments given together at the same time can help reduce bad outcomes and deaths from sepsis. These groups of treatments are sometimes called "treatment bundles". Because of this research, and the importance of tackling maternal sepsis worldwide, a treatment bundle was developed specifically for maternal sepsis. This treatment bundle is called FAST-M and was developed to be used in resource-poor settings and been tested in lots of facilities so we know it can be used to improve care. The next important research question our team would like to answer is in which women the FAST-M treatment bundle should be started. In high income settings and the general adult population, a blood test is commonly used to help gauge which patients are most unwell from sepsis and at risk of poor outcomes. This blood test measures an acid in the blood called Lactate, which is a helpful test to identify people who need the most urgent treatment. A small hand-held machine can now be used to measure Lactate which means it could be used even in placed that don't have proper laboratory facilities.However, it is not currently known what happens to lactate when a pregnant or recently pregnant adult has an infection, or if the test works as well if used in low resource setting. Changes in the body around pregnancy and childbirth alter how the body responds to infection which may also alter how the test works. Our team wants to find out if using a rapid lactate test is better than routine observations in identifying women most likely have maternal sepsis and to suffer poor outcomes. We intend to conduct this research in 3 countries; Malawi, Pakistan and Uganda. We will identify cases of maternal infection within the hospital sites. After gaining the permission of these women we will add taking a blood sample for lactate testing. We will not change the usual treatment but follow what happens to these women till they are discharged from hospital. We will look at the results of the lactate test, compared to usual observations to see how it compares in diagnosing maternal sepsis, and in predicting poor outcomes. In the second part of the study we want to find out if using this lactate test as part of maternal sepsis care, linked to the FAST-M bundle is possible in low resource settings, and what makes this easier or more difficult. To do this we will use sites in Uganda and Pakistan and see how it Lactate testing works when used. We will look carefully at how staff find using it by measuring what happens to patients and if it has been used correctly and reliably. We will also give questionnaires to staff and talk in detail to healthcare workers and others in the facility to find out their opinions about the test.This research will help us to know if using the lactate blood test is useful to diagnose cases of maternal sepsis and how the testing can be used in resource limited facilities to improve care. We hope this information will help reduce deaths and poor outcomes from cases of maternal sepsis worldwide.