Remote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).

M♡THer, an mHealth System to Support Women with Gestational Diabetes Mellitus: Feasibility and Acceptability Study.

Background: Gestational diabetes mellitus (GDM) is defined as glucose intolerance first identified during pregnancy. Delays in diagnosis and challenges in management can lead to serious adverse outcomes for the mother and child. As rates of GDM diagnosis increase worldwide, health systems and maternity services have become increasingly strained, especially with new restrictions around in-person care due to the current COVID-19 pandemic. Mobile health (mHealth) has increasingly shown promise for management of chronic disease, driven by smartphone adoption and increased internet connectivity. The aim of this work was to evaluate the adoption and multidisciplinary care coordination of an mHealth platform called M♡THer in a cohort of women with first-time diagnosis of GDM. Methods: The mHealth platform for GDM management was developed incorporating a smartphone application, clinician portal, and secure cloud data storage. Forty participants with a first-time diagnosis of GDM were recruited to use the app during their pregnancy. User attitudes from clinicians and women were captured through post-hoc surveys, and app-usage metrics. Results: Clinicians and women indicated satisfaction and ease of use of the mHealth platform, with some technological challenges around wireless connectivity. Blood glucose reviews and antenatal contact were higher with use of the M♡THer app compared with a matched historical sample. Conclusion: The M♡THer mHealth platform is a new comprehensive tool for health care of women with GDM, and may provide an effective new avenue to enhance multidisciplinary care in the face of COVID-19 disruptions and challenges to traditional care pathways.