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

背景：每天约有800名妇女死于怀孕或分娩。其中99%的死亡发生在发展中国家。获得医疗保健机会有限的妇女面临的风险最大。许多妇女在怀孕期间死亡，因为问题被发现得太晚。我们有使用简单、准确的手持式设备（CRADLE VSA）以最低技能测量血压和脉搏的经验。它使用一个“交通灯”系统;该设备告诉用户血压和脉搏测量结果是正常的（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，需要进一步的工作来确定死亡风险最大的妇女。我们之前在非洲的工作表明，肌酐（肾功能的标志物）升高的女性表明急性肾损伤（阿基）更容易死亡。阿基是肾功能的突然丧失，许多病例是可以预防的。阿基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，阿基的费用很高，特别是如果需要进行挽救生命的透析。阿基后母亲的长期问题，包括慢性肾脏疾病，心脏病和先兆子痫（高血压和尿蛋白）在未来的怀孕。如果母亲患有阿基，早产婴儿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。由于不需要采血和实验室处理，因此手指采血的肌酐（POC-Cr）护理点检测非常适合低收入环境。但是，尚未进行妊娠期POC-Cr检测以在早期阶段识别阿基，此时治疗可能会成功。在未来，我们认为在低收入环境中使用POC-Cr预防妊娠期阿基可能会减少母亲和婴儿的死亡。本研究的目的是制定：-在妊娠或产后妇女中进行POC-Cr检测有多容易：我们将测量测试失败的数量，培训所需时间和测试所需时间-与常规血肌酐浓度测试相比，POC-Cr测试的准确性如何-POC-Cr检测对医疗保健提供者和女性来说是可接受的-有多少女性有阿基的风险，有多少人发展为AKI-在怀孕期间完成POC-Cr研究并分析结果需要多长时间-从研究开始和6-8小时时POC-Cr检测值的增加表明阿基可能在24小时内发展？方法：我们将招募2000名CRADLE VSA读数异常的孕妇。所有妇女将拥有：i）入院时/阿基事件发生时以及6-8小时后再次进行的POC-Cr ii）入院时/阿基事件发生时以及24小时导入期（6个月）再次进行的血肌酐测试：1000名女性-临床团队不会看到POC-Cr结果。我们将比较POC-Cr结果与血液实验室检查。我们将根据24小时内的血肌酐变化计算出发生阿基的女性人数，并计算出6-8小时内测量的POC-Cr增加最能预测哪些女性在24小时内发生阿基。干预期（6个月）：1000名孕妇-临床团队将观察POC-Cr结果。临床团队还将接受阿基护理方面的培训，并建议对6-8小时POC-Cr升高的女性进行培训，这预示着她们可能在24小时内发生阿基。我们将比较有多少女性在导入期和干预期获得阿基。后续步骤：这项研究的结果将用于设计一项大型国际研究，该研究将研究POC-Cr检测是否可以减少低收入国家的阿基病例数、孕产妇和新生儿死亡。

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.