School of Medicine, Western Sydney University, Penrith, NSW, Australia.
Department of Medicine, Campbelltown Hospital, South Western Sydney Local Health District, Campbelltown, NSW, Australia.
Trials. 2023 May 17;24(1):334. doi: 10.1186/s13063-023-07321-0.
Pregnant women at high risk for developing a hypertensive disorder of pregnancy require frequent antenatal assessments, especially of their blood pressure. This expends significant resources for both the patient and healthcare system. An alternative to in-clinic assessments is a remote blood pressure monitoring strategy, in which patients self-record their blood pressure at home using a validated blood pressure machine. This has the potential to be cost-effective, increase patient satisfaction, and reduce outpatient visits, and has had widespread uptake recently given the increased need for remote care during the ongoing COVID-19 pandemic. However robust evidence supporting this approach over a traditional face-to-face approach is lacking, and the impact on maternal and foetal outcomes has not yet been reported. Thus, there is an urgent need to assess the efficacy of remote monitoring in pregnant women at high risk of developing a hypertensive disorder of pregnancy.
The REMOTE CONTROL trial is a pragmatic, unblinded, randomised controlled trial, which aims to compare remote blood pressure monitoring in high-risk pregnant women with conventional face-to-face clinic monitoring, in a 1:1 allocation ratio. The study will recruit patients across 3 metropolitan Australian teaching hospitals and will evaluate the safety, cost-effectiveness, impact on healthcare utilisation and end-user satisfaction of remote blood pressure monitoring.
Remote blood pressure monitoring is garnering interest worldwide and has been increasingly implemented following the COVID-19 pandemic. However, robust data regarding its safety for maternofoetal outcomes is lacking. The REMOTE CONTROL trial is amongst the first randomised controlled trials currently underway, powered to evaluate maternal and foetal outcomes. If proven to be as safe as conventional clinic monitoring, major potential benefits include reducing clinic visits, waiting times, travel costs, and improving delivery of care to vulnerable populations in rural and remote communities.
The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).
患有妊娠高血压疾病高危风险的孕妇需要频繁的产前评估，尤其是血压评估。这会给患者和医疗保健系统带来巨大的资源消耗。替代门诊评估的方法是远程血压监测策略，即患者在家使用经过验证的血压计自行记录血压。这种方法具有成本效益高、提高患者满意度、减少门诊就诊次数的潜力，并且由于在持续的 COVID-19 大流行期间对远程护理的需求增加，最近已经得到了广泛应用。然而，目前缺乏支持这种方法优于传统面对面方法的强有力证据，并且其对母婴结局的影响尚未报道。因此，迫切需要评估远程监测在患有妊娠高血压疾病高危风险的孕妇中的效果。
REMOTE CONTROL 试验是一项实用的、非盲的、随机对照试验，旨在比较远程血压监测在高危孕妇中的应用与传统的面对面门诊监测，采用 1:1 分配比例。该研究将在澳大利亚 3 家大都市教学医院招募患者，并将评估远程血压监测的安全性、成本效益、对医疗保健利用的影响和最终用户满意度。
远程血压监测在全球范围内受到关注，并在 COVID-19 大流行后得到了越来越多的应用。然而，其对母婴结局的安全性的可靠数据仍缺乏。REMOTE CONTROL 试验是目前正在进行的首批随机对照试验之一，其目的是评估母婴结局。如果证明与传统的门诊监测一样安全，那么主要的潜在好处包括减少门诊就诊次数、等待时间、旅行成本，并改善向农村和偏远社区的弱势人群提供的护理。
该试验已在澳大利亚和新西兰临床试验注册中心（ACTRN12620001049965p，于 2020 年 10 月 11 日）进行了前瞻性注册。
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