Hans van den Heuvel

adoption by the end-users. Therefore, patient safety and effectiveness of telemonitoring compared to antenatal admission have yet to be examined in a prospective trial. In the HOTEL trial, a multicentre randomised controlled trial, we aim to compare hospital care to telemonitoring in high-risk pregnancy requiring daily monitoring. We will evaluate patient safety and clinical effectiveness as well as patient satisfaction and cost effectiveness of both strategies. METHODS Design and setting This ongoing multicentre randomised controlled trial will be performed in 6 Dutch perinatal care units, including 2 university hospitals. The study will be open label. The trial protocol was registered in September 2016 (NTR6076) and first inclusion took place in December 2016. Patient and public involvement Prior to the start of the trial, pregnant womenwere involved in study set up. A pilot study was performed to check feasibility and acceptance of telemonitoring in pregnancy (see under Introduction). In focus groups, women with either antenatal admission or participation in the telemonitoring pilot joined our focus group studies (total n = 22) to report on satisfaction of antenatal care. Hospitalized patients recalled anxiety, boredom and concerns about privacy on ward. Their family life was disturbed because of frequent travelling of partners and worries over their other child(s). The patients in the home telemonitoring group reported that use of the monitoring devices was uncomplicated after instruction. They reported relief about sleeping at home, better food, seeing partners and first child(s) more often and good feeling of security with at home monitoring and weekly face-to-face visits. With use of these focus group interviews, the telemonitoring strategy and study communications were improved and we developed the questionnaire that is used at the end of the study period. Eligibility criteria Definitions of the inclusion criteria are fully described in Table 1. Eligible women must be ≥ 18 years old with a singleton pregnancy ≥ 26+0 weeks gestational age requiring hospital admittance for maternal or fetal surveillance for one (or multiple) of the following reasons: (1) preeclampsia; (2) preterm prelabour rupture of membranes (PPROM) without contractions; (3) fetal growth restriction (FGR); (4) recurrent reduced fetal movements; (5) fetal anomaly requiring daily monitoring (e.g. fetal gastroschisis); (6) intrauterine fetal death in previous pregnancy. Exclusion criteria for participation in the study are (1) pregnancy complications requiring CHAPTER 10 166