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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

Greig Dougall Orcid Logo, Marloes Franssen, Katherine Louise Tucker Orcid Logo, Ly-Mee Yu, Lisa Hinton Orcid Logo, Oliver Rivero-Arias, Lucy Abel, Julie Allen, Becky Band Orcid Logo, Alison Chisholm, Carole Crawford, Marcus Green, Sheila Greenfield, James Hodgkinson, Paul Leeson, Christine McCourt, Lucy MacKillop Orcid Logo, Alecia Nickless, Jane Sandall, Mauro Santos, Lionel Tarassenko, Carmelo Velardo, Hannah Wilson, Lucy Yardley, Lucy Chappell, Richard J McManus Orcid Logo

BMJ Open, Volume: 10, Issue: 1, Start page: e034593

Swansea University Author: Becky Band Orcid Logo

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DOI (Published version): 10.1136/bmjopen-2019-034593

Abstract

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 raise...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2023
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URI: https://cronfa.swan.ac.uk/Record/cronfa67029
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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.</abstract><type>Journal Article</type><journal>BMJ Open</journal><volume>10</volume><journalNumber>1</journalNumber><paginationStart>e034593</paginationStart><paginationEnd/><publisher>BMJ</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2044-6055</issnPrint><issnElectronic>2044-6055</issnElectronic><keywords/><publishedDay>10</publishedDay><publishedMonth>7</publishedMonth><publishedYear>2023</publishedYear><publishedDate>2023-07-10</publishedDate><doi>10.1136/bmjopen-2019-034593</doi><url/><notes>Correction: Blood pressure monitoring in high risk pregnancy to improve the detection and monitoring of hypertension (The BUMP 1&amp;2 trials): protocol for two linked randomised controlled trials available at https://doi.org/10.1136/bmjopen-2019-034593corr1</notes><college>COLLEGE NANME</college><department>Health and Social Care School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HSOC</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This work is funded from a National Institute for Health Research (NIHR) Programme grant for applied research (RP- PG-1209-10051) and an NIHR Professorship awarded to RJM (NIHR- RP- R2-12-015). RJM and KLT receive funding from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust. JS is a National Institute for Health Research (NIHR) Senior Investigator and supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South London (NIHR CLAHRC South London) at King’s College Hospital NHS Foundation Trust. 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spelling v2 67029 2024-07-09 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 06b53a31f254b004de8649a376ce2fbd 0000-0001-5403-1708 Becky Band Becky Band true false 2024-07-09 HSOC 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. Journal Article BMJ Open 10 1 e034593 BMJ 2044-6055 2044-6055 10 7 2023 2023-07-10 10.1136/bmjopen-2019-034593 Correction: Blood pressure monitoring in high risk pregnancy to improve the detection and monitoring of hypertension (The BUMP 1&2 trials): protocol for two linked randomised controlled trials available at https://doi.org/10.1136/bmjopen-2019-034593corr1 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University This work is funded from a National Institute for Health Research (NIHR) Programme grant for applied research (RP- PG-1209-10051) and an NIHR Professorship awarded to RJM (NIHR- RP- R2-12-015). RJM and KLT receive funding from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust. JS is a National Institute for Health Research (NIHR) Senior Investigator and supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South London (NIHR CLAHRC South London) at King’s College Hospital NHS Foundation Trust. Service support costs will be administered through the NIHR Clinical Research Network. 2024-09-02T14:45:52.7274446 2024-07-09T15:23:31.1345441 Faculty of Medicine, Health and Life Sciences School of Psychology Greig Dougall 0000-0001-9751-1998 1 Marloes Franssen 2 Katherine Louise Tucker 0000-0001-6544-8066 3 Ly-Mee Yu 4 Lisa Hinton 0000-0002-6082-3151 5 Oliver Rivero-Arias 6 Lucy Abel 7 Julie Allen 8 Becky Band 0000-0001-5403-1708 9 Alison Chisholm 10 Carole Crawford 11 Marcus Green 12 Sheila Greenfield 13 James Hodgkinson 14 Paul Leeson 15 Christine McCourt 16 Lucy MacKillop 0000-0002-1927-1594 17 Alecia Nickless 18 Jane Sandall 19 Mauro Santos 20 Lionel Tarassenko 21 Carmelo Velardo 22 Hannah Wilson 23 Lucy Yardley 24 Lucy Chappell 25 Richard J McManus 0000-0003-3638-028x 26 67029__31224__01baf97c911c4ba4ac37b52bc4345665.pdf 67029.VoR.pdf 2024-09-02T14:44:13.3121857 Output 6083175 application/pdf Version of Record true This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license. true eng https://creativecommons.org/licenses/by/4.0/
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
spellingShingle 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
Becky Band
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_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_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
author_id_str_mv 06b53a31f254b004de8649a376ce2fbd
author_id_fullname_str_mv 06b53a31f254b004de8649a376ce2fbd_***_Becky Band
author Becky Band
author2 Greig Dougall
Marloes Franssen
Katherine Louise Tucker
Ly-Mee Yu
Lisa Hinton
Oliver Rivero-Arias
Lucy Abel
Julie Allen
Becky Band
Alison Chisholm
Carole Crawford
Marcus Green
Sheila Greenfield
James Hodgkinson
Paul Leeson
Christine McCourt
Lucy MacKillop
Alecia Nickless
Jane Sandall
Mauro Santos
Lionel Tarassenko
Carmelo Velardo
Hannah Wilson
Lucy Yardley
Lucy Chappell
Richard J McManus
format Journal article
container_title BMJ Open
container_volume 10
container_issue 1
container_start_page e034593
publishDate 2023
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2019-034593
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Psychology{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Psychology
document_store_str 1
active_str 0
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.
published_date 2023-07-10T14:45:51Z
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