Assessment of Point of CaRe creatinine testing In pregnancy: a feasibilty Cohort sTudy in Sierra Leone (APRICOT-SL)

背景：每天大约有800名妇女死于怀孕或分娩。所有这些死亡中的99%发生在发展中国家。获得医疗保健机会有限的女性面临的风险最大。许多女性在怀孕期间死亡，因为意识到问题为时已晚。我们有使用简单、准确、手持设备(摇篮VSA)测量血压和脉搏的经验，技能最低。它使用了一个“红绿灯”系统；该设备告诉用户血压和脉搏的测量结果是正常的(绿色)、令人担忧的(琥珀色)还是严重异常的(红色)，从而突出那些身体不适的人；然而，还需要进一步的工作来识别死亡风险最大的女性。我们之前在非洲的研究表明，肌酐升高(肾功能的一个标志)表明急性肾损伤(AKI)的女性更有可能死亡。AKI是指肾功能的突然丧失，许多病例是可以预防的。AKI导致所有妊娠并发症的数量增加。由于住院时间较长和额外的治疗费用，AKI的成本很高，特别是在需要挽救生命的透析的情况下。AKI后母亲面临的长期问题包括慢性肾脏疾病、心脏病和未来怀孕期间的先兆子痫(高血压和尿蛋白)。如果母亲患有AKI，婴儿的早产也可能导致婴儿死亡和短期和长期的健康问题，包括未来的慢性肾脏疾病。手指刺血的护理点肌酐测试(POC-Cr)是低收入环境的理想选择，因为不需要采血和实验室处理。但是，在治疗有可能成功的早期阶段，通过孕期的POC-Cr检测来确定AKI，还没有进行。未来，我们认为在低收入环境下使用POC-CR预防怀孕期间的AKI可能会减少母亲和婴儿的死亡。这项研究的目的是找出：-在孕妇或产后进行POC-CR测试有多容易：我们将衡量测试失败的数量，培训所用的时间和检测所用的时间--POC-Cr检测与常规血肌酐浓度检测的精确度如何--POC-CR检测是否可以被卫生保健提供者和妇女接受--多少女性有AKI的风险，有多少人患上AKI--完成怀孕期间的POC-CR研究并分析结果需要多长时间--研究开始后和6-8小时内POC-CR检测值的增加意味着24小时内可能发生AKI？--如果重复POC-CR检测和治疗AKI的培训，AKI发生率将会降低的估计方法：我们招募2000名摇篮VSA读数异常的孕妇。所有女性在入院时/AKI事件发生时和6-8小时后再次进行POC-Cr检查。入院时/AKI事件发生时在24小时内(6个月)再次进行血肌酐测试：1000名女性-POC-CR结果不会被临床团队看到。我们会将POC-CR结果与血液化验结果进行比较。我们将根据24小时内血肌酐的变化计算发生AKI的女性人数，并计算出在6-8小时测量的POC-Cr增加对预测哪些女性在24小时患上AKI是最好的。干预期(6个月)：1000名孕妇-临床团队将看到POC-Cr结果。临床团队还将接受AKI护理方面的培训，建议对POC-Cr在6-8小时内上升的女性进行培训，这预示着她们可能在24小时内发展为AKI。我们将比较在磨合期和干预期有多少女性患上了AKI。下一步：这项研究的结果将被用于设计一项大型国际研究，以确定POC-Cr检测是否可以减少低收入国家的AKI、孕产妇和新生儿死亡病例的数量。

Background: Every day, approximately 800 women die in pregnancy or childbirth. 99% of all of these deaths occur in the developing world. Women with limited access to healthcare are at the greatest risk. Many women die in pregnancy because problems are recognised too late. We have experience using a simple, accurate, handheld device (CRADLE VSA) to measure blood pressure and pulse with minimal skill. It uses a 'traffic light' system; the device tells the user if the blood pressure and pulse measurements are normal (green), worrying (amber) or severely abnormal (red) thus highlighting those who are unwell; however, further work is needed to identify women at greatest risk of death. Our previous work in Africa showed that women with raised creatinine (a marker of kidney function) indicating acute kidney injury (AKI) were more likely to die. AKI is the sudden loss of kidney function and many cases are preventable. AKI leads to an increase in number of all pregnancy complications. Costs of AKI are high due to longer length of stay and extra treatment costs, especially if life-saving dialysis is needed. Longer term problems for the mother after AKI including chronic kidney disease, heart disease and pre-eclampsia (high blood pressure and urine protein) in future pregnancies. Early delivery of the baby, if the mother has AKI, also may lead to infant death and short and long term health problems including future chronic kidney disease.Point of care testing of creatinine (POC-Cr) on finger prick blood is ideal for low income settings as blood taking and laboratory processing are not required. But POC-Cr testing in pregnancy to identify AKI at early stages, when treatments are likely to be successful, has not been performed. In the future we think that preventing AKI in pregnancy using POC-Cr in low income settings could lead to a reduction in death of mother and baby.The aim of this study is to work out: -How easy it is to do POC-Cr testing in pregnant or postpartum women: we will measure number of test failures, time taken for training and time taken for testing-How accurate POC-Cr testing is compared to routine blood creatinine concentration testing -Whether POC-Cr testing is acceptable to health care providers and women-How many women are at risk of AKI and how many develop AKI-How long it takes to complete a POC-Cr study in pregnancy and analyse the findings -What increase in POC-Cr testing value from study entry and at 6-8 hours indicates the likely development of AKI at 24 hours? -An estimate of the reduction in AKI rate if repeat POC-Cr testing and training to treat AKI is usedMethod: We will recruit 2000 pregnant women with abnormal CRADLE VSA readings. All women will have: i) POC-Cr at admission/at time of AKI event and again after 6-8 hoursii) Blood creatinine test at admission/ at time of AKI event again at 24 hours Run-in period (6 months): 1000 women - POC-Cr results will not be seen by the clinical team. We will compare POC-Cr results with blood laboratory tests. We will calculate the number of women who develop AKI from blood creatinine changes at 24 hours and work out what increase in POC-Cr measured at 6-8 hours is best at predicting which women get AKI at 24 hours. Intervention period (6 months): 1000 pregnant women - POC-Cr results will be seen by the clinical team. The clinical team will also have training in AKI care and it will be recommended that this is given to women who have a rise POC-Cr measured at 6-8 hours which predicts that they might develop AKI at 24 hours. We will compare how many women get AKI in the run-in period and in the intervention period. Next steps: The results of this study will be used to design a large international study which will work out if POC-Cr testing can reduce the number of cases of AKI, maternal and neonatal death in low income countries.