Hans van den Heuvel

Future studies Unanswered questions remain on blood pressure telemonitoring in high-risk or hypertensive pregnancies. There is a need for studies elucidating the effects of telemonitoring in early detection of complications, rare adverse perinatal outcomes, prevention of severe hypertensionanddecisionmakingonearly interventions. Therefore, (more) largeprospective trials are necessary. Randomized trials must be adequately sized to assess if self-monitoring in pregnancy can improve the detection of raised blood pressure and its consequences on perinatal outcome. 18-19 The UK-based BUMP project conducts two linked multicentre RCTs: one for women at higher risk of hypertension in pregnancy, and one for women with chronic or gestational hypertension. The interventional arm starts with self-monitoring of blood pressure around 2 weeks of gestation but without in-hospital monitoring of results / alarms. Primary outcomes for the study’s sample size calculation are: time to first raised blood pressure and change in mean blood pressure between baseline measurement and delivery. Secondary outcomes include maternal and perinatal outcomes as well as process and costs evaluations. As inclusion of the BUMP trials is completed with almost 2800 participants, we are looking forward to the results. In the meantime, a large prospective implementation study of the SAFE@HOME strategy will be performed in the Netherlands. This study will evaluate medical outcomes as well as qualitative data to enable the development of the best possible implementation strategy on a national scale. This includes viewpoints of health care provides as well as patients. For telemonitoring of maternal and fetal condition in complicated pregnancies, the results of the HOTEL trial will report on perinatal safety, amongst others. As most studies on telemonitoringinhigh-riskpregnancy,theHOTELtrialwillalsobeproventobeunderpowered to assess adverse maternal, fetal and neonatal outcomes. Therefore, future prospective studies must demonstrate the effects of digital technology in the light of evaluation of (rare) adverse events in perinatal care. In recent years, questions arise around the design of randomized-controlled trials, as it can possibly not keep up with the speed of innovation. 20 However, robust evidence remains highly relevant. Traditionally, the RCT is considered the gold standard for efficacy evaluation. As RCTs study highly selective populations, and are managed in a tightly controlled setting, those may fail to represent a wider population or “real-world-medicine”. Inclusion of a control arm, especially in digital health research, may become difficult as personalized medicine becomes increasingly common, affecting participant recruitment for RCTs. Moreover, other drawbacks of RCT’s are extensive costs and time needed for preparations, data collection and analysis. The feasibility of conducting large RCTs in pregnant women is therefore questionable for multiple reasons. CHAPTER 11 184