Chmielewska Basia, Reading Isabel, Bhide Amarnath, Ganapathy Ramesh, Thilaganathan Baskaran
Department of Obstetrics and Gynaecology, St George's University Hospitals NHS Foundation Trust, London, UK.
St George's University of London, London, UK.
BMJ Open. 2025 Jun 18;15(6):e094421. doi: 10.1136/bmjopen-2024-094421.
Hypertensive disorders of pregnancy (HDP), including gestational hypertension and pre-eclampsia, affect approximately 10% of pregnancies worldwide and contribute significantly to fetal and maternal morbidity and mortality. Early identification of HDP would facilitate targeted surveillance and personalised care in order to mitigate the severity of complications and improve pregnancy outcomes. Uric acid is a marker of oxidative stress, inflammation and endothelial dysfunction, and has been proposed as a predictor of hypertensive disease. Salurate is a salivary uric acid test that has the potential to identify pregnant women at risk of developing HDP several weeks before clinical manifestation.
This is a prospective, multicentre, observational, cohort study with health economics evaluation. Women aged 16 and above, with a viable singleton pregnancy at <16 weeks gestation and a combined first trimester pre-eclampsia risk of >1:300 will be eligible for recruitment. Participants will perform weekly remote salivary uric acid testing from enrolment until the conclusion of pregnancy and upload results of colourimetric paper tests via a smartphone application. We will validate a predictive algorithm that analyses colour data from several consecutive samples to detect patterns that predict whether HDP is likely to occur. The primary outcome is test performance for the prediction of HDP. Secondary outcomes include adherence to sampling and test performance for predicting gestational diabetes, stillbirth and fetal growth restriction. Data on pregnancy outcomes will be collected from the medical notes, compared with the predictions made by the algorithm and subjected to statistical analysis.
Approval has been obtained from Cambridge East Research Ethics Committee (REC reference 24/EE/0123), Medicines and Healthcare products Regulatory Agency (CI/2024/0038/GB) and Health Research Authority (IRAS ID 337290). Results of the study will be published in peer-reviewed journals and presented at national and international conferences.
ISRCTN17992452.
4, 4 July 2024.
妊娠高血压疾病（HDP），包括妊娠期高血压和子痫前期，影响着全球约10%的妊娠，并对胎儿和孕产妇的发病率及死亡率有重大影响。早期识别HDP将有助于进行有针对性的监测和个性化护理，以减轻并发症的严重程度并改善妊娠结局。尿酸是氧化应激、炎症和内皮功能障碍的标志物，并已被提议作为高血压疾病的预测指标。唾液尿酸检测是一种唾液尿酸测试，有可能在临床表现出现前数周识别出有发生HDP风险的孕妇。
这是一项具有卫生经济学评估的前瞻性、多中心、观察性队列研究。年龄在16岁及以上、妊娠小于16周且单胎存活、孕早期子痫前期综合风险大于1:300的妇女将有资格被招募。参与者将从入组开始直至妊娠结束每周进行远程唾液尿酸检测，并通过智能手机应用程序上传比色纸测试结果。我们将验证一种预测算法，该算法分析来自几个连续样本的颜色数据，以检测预测HDP是否可能发生的模式。主要结局是预测HDP的测试性能。次要结局包括采样依从性以及预测妊娠期糖尿病、死产和胎儿生长受限的测试性能。妊娠结局数据将从病历中收集，与算法做出的预测进行比较，并进行统计分析。
已获得剑桥东部研究伦理委员会（REC编号24/EE/0123）、药品和保健产品监管局（CI/2024/0038/GB）以及卫生研究管理局（IRAS ID 337290）的批准。研究结果将发表在同行评审期刊上，并在国内和国际会议上展示。
ISRCTN17992452。
2024年7月4日第4版。
