Hans van den Heuvel

10 INTRODUCTION For pregnant women diagnosed with complications, increased monitoring and observation of maternal and fetal parameters is recommended. 1 The aim of daily monitoring in high-risk pregnancies is to assess fetal and maternal condition using tests such as blood pressure (BP), urinary and blood analysis and cardiotocography (CTG). This increased surveillance essentially leads to antenatal hospitalisation in up to 11%of pregnancies, mostly for preterm rupture of membranes (PROM), fetal growth restriction (FGR), (gestational) diabetes mellitus, imminent preterm birth, fetal anomalies, and hypertensive disorders including preeclampsia (PE). 2,3,4 These admissions, often until delivery, result in dissatisfaction with the in-hospital stay, family burden and significant costs. 5,6 Recent technological advancements in health care (eHealth) have resulted in remote monitoring platforms, mobile device-supported care, telemedicine and teleconsultation. 7 eHealth has the potential to increase patient engagement and empowerment and create better access to health care while reducing the necessity for hospital visits or admittance. 8 Pregnant women are frequent users of smartphones and internet, and therefore already equipped with the hardware to take self-measurements at home and the mind-set to communicate these digitally with their prenatal care professional. 9 Telemonitoring of pregnancy is perceived to be one of the most promising answers to the possibilities of e-health in antenatal care. Using a validated automated blood pressure monitoring device (Microlife WatchBP) and a wireless, portable CTG system (Sense4Baby), a telemonitoring strategy could replace hospital admission that require these types of monitoring. 10,11 Measurements, self-recorded by the pregnant women at home, are saved on the included tablet in a personal profile. Using a secured Internet portal, the data are integrated in the electronic patient record system enabling access for health care professionals. A pilot study (n=76) using the Sense4Baby system was performed in UMC Utrecht to examine the accuracy of the tracings, the system’s usability and participants’ experiences and acceptability. Feedback and experiences from participants were positive about the used technology and no clinical relevant adverse events occurred (unpublished data, see also Patient involvement under Methods). Currently, no clinical trials have evaluated this novel strategy with telemonitoring of self- recorded data in high-risk pregnancy before. While the patient at home will take care of measurements of CTG and blood pressure, a considerable amount of time could be saved on hospital ward or outpatient clinic for health care providers. Telemonitoring might therefore reduce costs and might offer a more acceptable form of pregnancy care. 12 However, risks of unevaluated implementation of digital innovations include usability problems, issues regarding safety and reimbursement, and adverse effects, resulting in disappointing HOTEL TRIAL STUDY PROTOCOL 165