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Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials
INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of rais...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044851/ https://www.ncbi.nlm.nih.gov/pubmed/31980512 http://dx.doi.org/10.1136/bmjopen-2019-034593 |
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author | Dougall, Greig Franssen, Marloes Tucker, Katherine Louise Yu, Ly-Mee Hinton, Lisa Rivero-Arias, Oliver Abel, Lucy Allen, Julie Band, Rebecca Jane Chisholm, Alison Crawford, Carole Green, Marcus Greenfield, Sheila Hodgkinson, James Leeson, Paul McCourt, Christine MacKillop, Lucy Nickless, Alecia Sandall, Jane Santos, Mauro Tarassenko, Lionel Velardo, Carmelo Wilson, Hannah Yardley, Lucy Chappell, Lucy McManus, Richard J |
author_facet | Dougall, Greig Franssen, Marloes Tucker, Katherine Louise Yu, Ly-Mee Hinton, Lisa Rivero-Arias, Oliver Abel, Lucy Allen, Julie Band, Rebecca Jane Chisholm, Alison Crawford, Carole Green, Marcus Greenfield, Sheila Hodgkinson, James Leeson, Paul McCourt, Christine MacKillop, Lucy Nickless, Alecia Sandall, Jane Santos, Mauro Tarassenko, Lionel Velardo, Carmelo Wilson, Hannah Yardley, Lucy Chappell, Lucy McManus, Richard J |
author_sort | Dougall, Greig |
collection | PubMed |
description | INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149 |
format | Online Article Text |
id | pubmed-7044851 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-70448512020-03-09 Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials Dougall, Greig Franssen, Marloes Tucker, Katherine Louise Yu, Ly-Mee Hinton, Lisa Rivero-Arias, Oliver Abel, Lucy Allen, Julie Band, Rebecca Jane Chisholm, Alison Crawford, Carole Green, Marcus Greenfield, Sheila Hodgkinson, James Leeson, Paul McCourt, Christine MacKillop, Lucy Nickless, Alecia Sandall, Jane Santos, Mauro Tarassenko, Lionel Velardo, Carmelo Wilson, Hannah Yardley, Lucy Chappell, Lucy McManus, Richard J BMJ Open Obstetrics and Gynaecology INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149 BMJ Publishing Group 2020-01-23 /pmc/articles/PMC7044851/ /pubmed/31980512 http://dx.doi.org/10.1136/bmjopen-2019-034593 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Obstetrics and Gynaecology Dougall, Greig Franssen, Marloes Tucker, Katherine Louise Yu, Ly-Mee Hinton, Lisa Rivero-Arias, Oliver Abel, Lucy Allen, Julie Band, Rebecca Jane Chisholm, Alison Crawford, Carole Green, Marcus Greenfield, Sheila Hodgkinson, James Leeson, Paul McCourt, Christine MacKillop, Lucy Nickless, Alecia Sandall, Jane Santos, Mauro Tarassenko, Lionel Velardo, Carmelo Wilson, Hannah Yardley, Lucy Chappell, Lucy McManus, Richard J Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials |
title | Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials |
title_full | Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials |
title_fullStr | Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials |
title_full_unstemmed | Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials |
title_short | Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials |
title_sort | blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the bump 1 and 2 trials): protocol for two linked randomised controlled trials |
topic | Obstetrics and Gynaecology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044851/ https://www.ncbi.nlm.nih.gov/pubmed/31980512 http://dx.doi.org/10.1136/bmjopen-2019-034593 |
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