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HOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial


- candidate number25306
- NTR NumberNTR6076
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2016
- Secondary IDsNL55884.041.16 METC 16/516
- Public TitleHOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial
- Scientific TitleHOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial
- ACRONYMHOTEL
- hypothesisTo prove that self-management at home in combination with telemedicine in high-risk pregnancies is safe, cost-effective and associated with high patient satisfaction.
- Healt Condition(s) or Problem(s) studiedE-health, Pregnancy, Pre-eclampsia
- Inclusion criteriaNecessity for hospital admittance for maternal or fetal surveillance because of one of the following: intrauterine growth retardation, preeclampsia, preterm premature rupture of membranes
- Exclusion criteria Maternal age <18 years
Pregnancy complications requiring intravenous therapeutics or obstetric intervention within 48 hours
Blood pressure >160/110 mmHg
Antepartum haemorrhage or signs of placental abruption
CTG registration with abnormalities indicating fetal distress or hypoxia
Multiple pregnancies
Place of residence 30 minutes driving away from the hospital
Insufficient knowledge of Dutch or English language or impossibility to understand the training or instructions of the devices
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2016
- planned closingdate1-jun-2018
- Target number of participants400
- InterventionsRandomisation will take place between traditional hospital admittance or telemonitoring for daily monitoring of maternal and fetal parameters. In telemonitoring pregnant women will make use of a wireless cardiotocograph registration device and home blood pressure monitor and will have daily telephone calls with an obstetric health care professional in the hospital. Weekly outpatient visits will be planned for real-time contact and ultrasound assessment, blood sampling or urinary analysis if necessary.
- Primary outcomepatient safety; composite of perinatal outcome is defined as perinatal mortality, a 5-minute Apgar score below 7 and/or an arterial pH below 7,05, maternal morbidity (such as eclampsia, HELLP syndrome, tromboembolic events), NICU admission of the newborn and emergency caesarean section
- Secondary outcomePatient satisfaction, quality of life and cost effectiveness will be assessed using validated questionnaires and one self developed survey to look for preferences for the new strategy will be developed
- Timepointsinclusion 18 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdrs J.F.M. (Hans) van den Heuvel
- CONTACT for SCIENTIFIC QUERIESdrs J.F.M. (Hans) van den Heuvel
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Stichting Achmea Gezondheidszorg (SAG), Telenatal
- Publications
- Brief summaryIn this study we aim to prove that self-management at home in combination with telemedicine in high-risk pregnancies is safe, cost-effective and associated with greater patient satisfaction. Pregnancies complicates with mild preeclampsia, intrauterine growth restriction or preterm rupture of membranes will be eligible for the study. In this study we will improve the use of the system by organizing hands-on training sessions for high-risk pregnant women teaching them how to handle the equipment. We expect that this facilitates the use of telemedicine at home irrespective of intelligence, technical skills, language barriers and socio-economic background. In this study the following specific objectives will be addressed: 1) to determine whether this novel obstetric care strategy is as safe as the currently provided care during hospital admission; 2) to evaluate the feasibility and cost-effectiveness of telemedicine in high-risk pregnant women remaining at home; 3) to evaluate patient experience and satisfaction with a user-friendly surveillance system at home compared to currently provided hospital care for the same indication
- Main changes (audit trail)
- RECORD19-sep-2016 - 11-nov-2016


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