None listed
Conditions
Brief summary
Hypertension is one of the most common complications of pregnancy, affecting 2-10% of pregnant women. It is associated with adverse maternal and fetal outcomes, such as eclampsia, stroke, fetal growth restriction and stillbirth. Maternal mortality approaches 15% globally. Monitoring, early recognition and treatment are key to reducing severe complications and mortality. Traditionally in pregnancy, blood pressure (BP) is monitored routinely at outpatient visits. However, major recent events - the Australian bushfires and the COVID-19 pandemic, limited social movement, and therefore initiated major change to antenatal healthcare delivery. There was widespread uptake of Telehealth services and home monitoring of BP. Patients are recording their own BP, directed by a healthcare professional on the frequency of monitoring, and given criteria as to when to attend the hospital. In non-pregnant populations, ambulatory and home BP measurements have been shown to have a closer association with long-term health effects, compared to clinic BP measurements. This is reflected in international guidelines, such as the American Heart Association, and the European Society of Hypertension guidelines, which emphasises the importance of BP self-monitoring. However, this practice is not validated in the pregnant population, and the effect on maternal and fetal outcomes has not been quantified. Our study is a multi-centre, cluster randomised controlled trial investigating antenatal home-based blood pressure monitoring when compared with usual care, through exploring maternal and perinatal outcomes, cost-effectiveness, compliance and qualitative patient satisfaction data. Home BP monitoring could provide more accurate data for clinicians to use in management strategies, thereby reducing poor fetal and maternal outcomes, and the burden of multiple clinic visits. Additionally, home-based monitoring would be useful in future events that would require our population to limit social movement, such as in bushfires and health pandemics.
Interventions
Interventional arm: Home-based blood pressure monitoring using an automated blood pressure monitor validated in pregnancy and preeclampsia (brand yet to be confirmed), in conjunction with an app-based system which will allow collection of blood pressure readings remotely. The app will be developed by the investigators of this study. Blood pressure will be recorded 3 times a week by participants. The readings will be transmitted automatically to the application which will transmit these readings to the clinicians dashboard. Participants in this arm will undergo education and training from the research nurse on the use of the automated BP machine and app-based system on the initial visit. This will be a one-on-one face-to-face education session, lasting 20 minutes. Instead of face-to-face consultations, care will subsequently occur remotely using Telehealth medicine by Obstetric physicians for review of symptoms and home-based blood pressure readings, to monitor and manage hypertensive disorders in pregnancy. The frequency of review will be dictated by the Obstetric physician based on clinical need, with at least 2 visits over the entire antepartum period, from enrolment in to the study to delivery. At least one further appointment in the postpartum period will occur from delivery to 6 weeks postpartum. Adherence will be assessed by the app-based system which will provide alerts if adherence with regular blood pressure monitoring is poor. These alerts will also be provided to the clinical team, who will review participant recordings on a weekly basis.
Sponsors
Study design
Eligibility
Inclusion criteria
Able to provide informed consent Able and willing to follow instructions for use of automated BP machine and app-based system Chronic hypertension (systolic BP >140 or diastolic BP >90) before 20 weeks’ gestation Gestational hypertension(systolic BP >140 or diastolic BP >90) after 20 weeks’ gestation Confirmation of viable intrauterine pregnancy on dating scan Enrolment before 37 weeks gestation
Exclusion criteria
Signs of severe preeclampsia on initial evaluation Inability to utilise smart phone device or app-based system Plan to terminate pregnancy