HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): Study protocol for a multicentre non-inferiority randomised controlled trial
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 (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 vers... Mehr ...
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Dokumenttyp: | Artikel |
Erscheinungsdatum: | 2019 |
Schlagwörter: | Adolescent / Adult / Blood Pressure Monitoring / Ambulatory/economics / Cardiotocography/economics / Clinical Protocols / Cost-Benefit Analysis / Female / Follow-Up Studies / Health Care Costs / Hospitalization/economics / Humans / Netherlands / Patient Safety / Patient Satisfaction / Pregnancy / Pregnancy Complications/diagnosis / High-Risk / Prenatal Care/economics / Prospective Studies / Telemedicine/economics / Treatment Outcome / Young Adult / Comparative Study / Journal Article / Multicenter Study / Randomized Controlled Trial / Research Support / Non-U.S. Gov't |
Sprache: | Englisch |
Permalink: | https://search.fid-benelux.de/Record/base-27612386 |
Datenquelle: | BASE; Originalkatalog |
Powered By: | BASE |
Link(s) : | https://dspace.library.uu.nl/handle/1874/439153 |
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 (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 ANALYSIS: The 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 DISSEMINATION: The study ...