Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.

International Journal of Security and Its Applications Pub Date : 2022-05-03 DOI:10.1001/jama.2022.4712

Katherine L Tucker, Sam Mort, Ly-Mee Yu, Helen Campbell, Oliver Rivero-Arias, Hannah M Wilson, Julie Allen, Rebecca Band, Alison Chisholm, Carole Crawford, Greig Dougall, Lazarina Engonidou, Marloes Franssen, Marcus Green, Sheila Greenfield, Lisa Hinton, James Hodgkinson, Layla Lavallee, Paul Leeson, Christine McCourt, Lucy Mackillop, Jane Sandall, Mauro Santos, Lionel Tarassenko, Carmelo Velardo, Lucy Yardley, Lucy C Chappell, Richard J McManus

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Abstract

Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy.

Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension.

Design, setting, and participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020.

Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP.

Main outcomes and measures: The primary outcome was time to first recorded hypertension measured by a health care professional.

Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group).

Conclusions and relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension.

Trial registration: ClinicalTrials.gov Identifier: NCT03334149.

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自我监测血压对高危妊娠期高血压诊断的影响：BUMP 1 随机临床试验。

重要性：血压（BP）升高处理不当是导致孕产妇死亡的一个重要因素。在普通人群中进行自我血压监测已被证明可改善高血压的诊断和管理，但在妊娠期使用这种方法却鲜为人知：目的：确定在高危妊娠中进行自我血压监测是否能更早地发现妊娠高血压：2018年11月至2019年10月期间，英国15家医院产科在平均妊娠20周时招募了2441名子痫前期风险较高的孕妇，纳入了该随机临床试验。最终随访于 2020 年 4 月完成：参与者被随机分配到血压自我监测与远程监测（n = 1223）加常规护理，或仅接受常规产前护理（n = 1218）而无法获得远程监测血压：主要结果和测量方法：主要结果是由医护人员测量首次记录到高血压的时间：在 2441 名随机参与者（平均 [SD] 年龄为 33 [5.6] 岁；平均妊娠期为 20 [1.6] 周）中，2346 人（96%）完成了试验。自我监测组（平均[标码]104.3 [32.6]天）与常规护理组（平均[标码]106.2 [32.0]天）从随机到门诊记录高血压的时间无显著差异（平均差异为-1.6天 [95% CI, -8.1 to 4.9]；P = .64）。试验期间共报告了 18 起严重不良事件，但没有一起被判定与干预措施有关（自我监测组为 12 [1%] 起，常规护理组为 6 [0.5%]起）：在先兆子痫风险较高的孕妇中，与常规护理相比，通过远程监测进行血压自我监测并不能显著提早在诊所发现高血压：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT03334149。

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International Journal of Security and Its Applications COMPUTER SCIENCE, INFORMATION SYSTEMS-

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期刊介绍： IJSIA aims to facilitate and support research related to security technology and its applications. Our Journal provides a chance for academic and industry professionals to discuss recent progress in the area of security technology and its applications. Journal Topics: -Access Control -Ad Hoc & Sensor Network Security -Applied Cryptography -Authentication and Non-repudiation -Cryptographic Protocols -Denial of Service -E-Commerce Security -Identity and Trust Management -Information Hiding -Insider Threats and Countermeasures -Intrusion Detection & Prevention -Network & Wireless Security -Peer-to-Peer Security -Privacy and Anonymity -Secure installation, generation and operation -Security Analysis Methodologies -Security assurance -Security in Software Outsourcing -Security products or systems -Security technology -Systems and Data Security