Hans van den Heuvel

ABSTRACT Introduction Pregnant women faced with complications of pregnancy often require long-term hospital admission for maternal and/or fetal monitoring. Antenatal admissions cause a burden to patients as well as hospital resources and costs. A telemonitoring platform connected to wireless cardiotocography (CTG) and automated blood pressure devices can be used for telemonitoring in pregnancy. Home telemonitoring might improve autonomy and reduce admissions and thus costs. The aim of this study is to compare the effects on patient safety, satisfaction and cost-effectiveness of hospital care versus telemonitoring (HOTEL) as an obstetric care strategy in high-risk pregnancies requiring daily monitoring. Methods and analysis The HOTEL trial is an ongoing multicentre randomized controlled clinical trial with a non-inferiority design. Eligible pregnant women are >26+0 weeks of singleton gestation requiring monitoring because of preeclampsia (hypertension with proteinuria), fetal growth restriction, preterm rupture of membranes without contractions, recurrent reduced fetal movements, or an intrauterine fetal death in a previous pregnancy. Randomisation takes place between traditional hospitalization versus telemonitoring until delivery. During telemonitoring pregnant women at home will use the Sense4Baby CTG device and Microlife blood pressure monitor and they will have daily telephone calls with an obstetric health care professional as well as weekly visits to the hospital. Primary outcome is a composite of adverse perinatal outcome, defined as perinatal mortality, 5-minute Apgar < 7 or arterial cord blood pH < 7.05, maternal morbidity (eclampsia, HELLP syndrome, thromboembolic event), neonatal intensive care admission and caesarean section rate. Patient satisfaction and preference of care will be assessed using validated questionnaires. We will perform an economic analysis. Outcomes will be analysed according to the intention to treat principle. Ethics and dissemination The study protocol was approved by the Ethics Committee of the Utrecht University Medical Center and the boards of all six participating centres. Trial results will be submitted to peer- reviewed journals. Trial registration NTR6076, (September 2016) CHAPTER 10 164