Journal Article

HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial

van den Heuvel, Josephus F M, Ganzevoort, Wessel, Deurloo, Koen L, van der Ham, David P, Seeber, Laura, Bekker, Mireille N, De Haan-Jebbink, Jiska M, Franx, Arie

2019

Overview

IntroductionPregnant 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 (BP) 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 analysisThe HOTEL trial is an ongoing multicentre randomised controlled clinical trial with a non-inferiority design. Eligible pregnant women are >26+0 weeks of singleton gestation requiring monitoring because of pre-eclampsia (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 hospitalisation (planned n=208) versus telemonitoring (planned n=208) until delivery. Telemonitoring at home is facilitated with Sense4Baby CTG devices, Microlife BP monitor and daily telephone calls with an obstetric healthcare professional as well as weekly hospital visits.Primary outcome is a composite of adverse perinatal outcome, defined as perinatal mortality, 5 min Apgar <7 or arterial cord blood pH <7.05, maternal morbidity (eclampsia, HELLP (hemolysis, elevated liver enzymes, and low platelets) 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 disseminationThe 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 numberNTR6076.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adolescent / Adult / Blood Pressure Monitoring, Ambulatory - economics / Blood Pressure Monitoring, Ambulatory - instrumentation / Blood Pressure Monitoring, Ambulatory - methods / Cardiotocography - economics / Cardiotocography - instrumentation / Cardiotocography - methods / Cost-Benefit Analysis / Economic analysis / eHealth / Equivalence Trials as Topic / Evidence-based medicine / Female / fetal growth restriction / fetal monitoring / Focus groups / Follow-Up Studies / Health Care Costs / high-risk pregnancy / home-based care / Hospitalization - economics / Humans / Intensive care / Multicenter Studies as Topic / Neonatal care / Netherlands / Obstetrics and Gynaecology / Patient Safety / Patient Satisfaction / Preeclampsia / Pregnancy / Pregnancy complications / Pregnancy Complications - diagnosis / Pregnancy Complications - therapy / Pregnancy, High-Risk / Premature birth / Prenatal Care - economics / Prenatal Care - methods / preterm birth / Prospective Studies / Randomized Controlled Trials as Topic / Telemedicine / Telemedicine - economics / Telemedicine - instrumentation / telemonitoring / Treatment Outcome / Womens health / Young Adult