TY - JOUR
T1 - HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL)
T2 - Study protocol for a multicentre non-inferiority randomised controlled trial
AU - Van Den Heuvel, Josephus F.M.
AU - Ganzevoort, Wessel
AU - De Haan-Jebbink, Jiska M.
AU - Van Der Ham, David P.
AU - Deurloo, Koen L.
AU - Seeber, Laura
AU - Franx, Arie
AU - Bekker, Mireille N.
N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/10/28
Y1 - 2019/10/28
N2 - 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 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 NUMBER: NTR6076.
AB - 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 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 NUMBER: NTR6076.
KW - Adolescent
KW - Adult
KW - Blood Pressure Monitoring, Ambulatory/economics
KW - Cardiotocography/economics
KW - Clinical Protocols
KW - Cost-Benefit Analysis
KW - Female
KW - Follow-Up Studies
KW - Health Care Costs
KW - Hospitalization/economics
KW - Humans
KW - Netherlands
KW - Patient Safety
KW - Patient Satisfaction
KW - Pregnancy
KW - Pregnancy Complications/diagnosis
KW - Pregnancy, High-Risk
KW - Prenatal Care/economics
KW - Prospective Studies
KW - Telemedicine/economics
KW - Treatment Outcome
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=85074294074&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-031700
DO - 10.1136/bmjopen-2019-031700
M3 - Article
C2 - 31662396
AN - SCOPUS:85074294074
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e031700
ER -