{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T06:38:46Z","timestamp":1791959926957,"version":"4.3.4"},"reference-count":19,"publisher":"BMJ","issue":"10","funder":[{"name":"BMA-Telenatal"},{"name":"Stichting Achmea Gezondheidszorg","award":["z659"],"award-info":[{"award-number":["z659"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,9,26]]},"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:italic>ho<\/jats:italic>\n                      spital care versus\n                      <jats:italic>tel<\/jats:italic>\n                      emonitoring (HOTEL) as an obstetric care strategy in high-risk pregnancies requiring daily monitoring.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The HOTEL trial is an ongoing multicentre randomised controlled clinical trial with a non-inferiority design. Eligible pregnant women are &gt;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.<\/jats:p>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>Primary outcome is a composite of adverse perinatal outcome, defined as perinatal mortality, 5 min Apgar &lt;7\u2009or arterial cord blood pH &lt;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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NTR6076.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-031700","type":"journal-article","created":{"date-parts":[[2019,10,29]],"date-time":"2019-10-29T06:57:48Z","timestamp":1572332268000},"page":"e031700","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":30,"title":["HOspital care versus TELemonitoring in high-risk pregnancy (HOTEL): study protocol for a multicentre non-inferiority randomised controlled trial"],"prefix":"10.1136","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1285-1019","authenticated-orcid":false,"given":"Josephus F M","family":"van den Heuvel","sequence":"first","affiliation":[{"name":"Obstetrics and Gynaecology, UMC Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wessel","family":"Ganzevoort","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, Amsterdam Universitair Medische Centra, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiska M","family":"De Haan-Jebbink","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David P","family":"van der Ham","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, Martini Ziekenhuis, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koen L","family":"Deurloo","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Seeber","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, Sint Antonius Hospital, Nieuwegein, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arie","family":"Franx","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, UMC Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mireille N","family":"Bekker","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, UMC Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,10,28]]},"reference":[{"key":"2025121602402190000_9.10.e031700.1","doi-asserted-by":"crossref","unstructured":"Queenan JT . Management of High\u2010Risk Pregnancy: John Wiley And Sons Ltd, 2012.","DOI":"10.1002\/9781119963783"},{"key":"2025121602402190000_9.10.e031700.2","unstructured":"NICE Guideline CG107 hypertension in pregnancy: diagnosis and management 2010"},{"key":"2025121602402190000_9.10.e031700.3","unstructured":"RCOG . Green-top Guideline No.31 - The Investigation and Management of the Small\u2013for\u2013Gestational\u2013Age Fetus, 2014."},{"key":"2025121602402190000_9.10.e031700.4","unstructured":"NICE . NICE Guideline NG25 preterm labour and birth, 2015. (accessed 15-11-2018)."},{"key":"2025121602402190000_9.10.e031700.5","doi-asserted-by":"crossref","unstructured":"Gourounti C , Karpathiotaki N , Vaslamatzis G . Psychosocial stress in high risk pregnancy. Int Arch Med 2015;8.doi:10.3823\/1694","DOI":"10.3823\/1694"},{"key":"2025121602402190000_9.10.e031700.6","doi-asserted-by":"publisher","DOI":"10.1007\/s40273-013-0096-8"},{"key":"2025121602402190000_9.10.e031700.7","unstructured":"World Health Organization . mHealth: new horizons for health through mobile technologies. global Observatory for eHealth series. 3. Geneva, Switzerland: WHO, 2011."},{"key":"2025121602402190000_9.10.e031700.8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1601705"},{"key":"2025121602402190000_9.10.e031700.9","doi-asserted-by":"crossref","DOI":"10.2196\/jmir.9262","article-title":"eHealth as the next-generation perinatal care: an overview of the literature","volume":"20","author":"van den Heuvel","year":"2018","journal-title":"J Med Internet Res"},{"key":"2025121602402190000_9.10.e031700.10","doi-asserted-by":"publisher","DOI":"10.1080\/10641950802601286"},{"key":"2025121602402190000_9.10.e031700.11","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0117043","article-title":"Wireless fetal heart rate monitoring in inpatient full-term pregnant women: testing functionality and acceptability","volume":"10","author":"Boatin","year":"2015","journal-title":"PLoS One"},{"key":"2025121602402190000_9.10.e031700.12","doi-asserted-by":"crossref","first-page":"470","DOI":"10.1016\/j.ijmedinf.2007.08.009","article-title":"Cost-Effectiveness of telemonitoring for high-risk pregnant women","volume":"77","author":"Buysse","year":"2008","journal-title":"Int J Med Inform"},{"key":"2025121602402190000_9.10.e031700.13","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1016\/j.jval.2016.01.003","article-title":"Dutch tariff for the five-level version of EQ-5D","volume":"19","author":"M Versteegh","year":"2016","journal-title":"Value Health"},{"key":"2025121602402190000_9.10.e031700.14","doi-asserted-by":"publisher","DOI":"10.1111\/j.2044-8260.1992.tb00997.x"},{"key":"2025121602402190000_9.10.e031700.15","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychores.2010.07.008"},{"key":"2025121602402190000_9.10.e031700.16","doi-asserted-by":"crossref","unstructured":"van der Ham DP , van der Heyden JL , Opmeer BC , et al . Management of late-preterm premature rupture of membranes: the PPROMEXIL-2 trial. Am J Obstet Gynecol 2012;207 doi:10.1016\/j.ajog.2012.07.024","DOI":"10.1016\/j.ajog.2012.07.024"},{"key":"2025121602402190000_9.10.e031700.17","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.c7087","article-title":"Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)","volume":"341","author":"Boers","year":"2010","journal-title":"BMJ"},{"key":"2025121602402190000_9.10.e031700.18","doi-asserted-by":"crossref","first-page":"2492","DOI":"10.1016\/S0140-6736(14)61998-X","article-title":"Immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy between 34 and 37 weeks of gestation (HYPITAT-II): an open-label, randomised controlled trial","volume":"385","author":"Broekhuijsen","year":"2015","journal-title":"The Lancet"},{"key":"2025121602402190000_9.10.e031700.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.preghy.2014.02.001"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2019-031700","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T10:40:28Z","timestamp":1765881628000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2019-031700"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10]]},"references-count":19,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2019,10,28]]},"published-print":{"date-parts":[[2019,10]]}},"alternative-id":["10.1136\/bmjopen-2019-031700"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2019-031700","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10]]}}}