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
Open accessAbstract
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
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Preliminary evidence on the optimal HBPM schedule in children showed that 6-day monitoring (no less than 3 days) with duplicate morning and evening measurements taken after few minutes rest in the sitting position is adequate, in line with evidence in adults.
“Preliminary evidence on the optimal HBPM schedule in children showed that 6-day monitoring (no less than 3 days) with duplicate morning and evening measurements taken after few minutes rest in the sitting position is adequate, which is in line with the evidence in the adults [186]”
From Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension (2021) · cites this paper as [186]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)
Herdman, M., Gudex, C., Lloyd, A., Janssen, M., Kind, P., Parkin, D., Bonsel, G., & Badia, X. (2011) · Quality of Life Research · doi:10.1007/s11136-011-9903-x · Cited by 9,795 · see citing works
Sample size in qualitative research
Sandelowski, M. (1995) · Research in Nursing & Health · doi:10.1002/nur.4770180211 · Cited by 4,372 · see citing works
WHO analysis of causes of maternal death: a systematic review
Khan, K. S., Wojdyla, D., Say, L., Gülmezoglu, A. M., & Van Look, P. F. (2006) · The Lancet · doi:10.1016/s0140-6736(06)68397-9 · Cited by 3,978 · see citing works
Marteau, T. M., & Bekker, H. (1992) · British Journal of Clinical Psychology · doi:10.1111/j.2044-8260.1992.tb00997.x · Cited by 3,238 · see citing works
Faria, R., Gomes, M., Epstein, D., & White, I. R. (2014) · PharmacoEconomics · doi:10.1007/s40273-014-0193-3 · Cited by 673 · see citing works
Flagged first, then by citations
Research works printed but not linked: 23
- [2]Douglas KA, Redman CW Eclampsia in the United Kingdom. BMJ 1994; 309: 1395– 400. 10.1136/bmj.309.6966.1395 7819845 PMC2541348 · DOI
- [3]Cantwell R, Clutton-Brock T, Cooper G, et al Saving mothers' lives: reviewing maternal deaths to make motherhood safer: 2006-2008. The eighth report of the Confidential enquiries into maternal deaths in the United Kingdom. BJOG 2011; 118 Suppl 1: 1– 203. 10.1111/j.1471-0528.2010.02847.x 21356004 · DOI
- [4]Knight M, Tuffnell D, Kenyon S Saving lives, improving mothers' care: surveillance of maternal deaths in the UK 2011-13 and lessons learned to inform maternity care from the UK and Ireland. confidential enquiries into maternal deaths and morbidity 2009-13. National Perinatal Epidemiology Unit, University of Oxford, 2015.
- [5]Hinton L, Tucker KL, Greenfield SM, et al Blood pressure self-monitoring in pregnancy (bump) feasibility study; a qualitative analysis of women's experiences of self-monitoring. BMC Pregnancy Childbirth 2017; 17: 427 10.1186/s12884-017-1592-1 29258469 PMC5735874 · DOI
- [6]Tucker KL, Taylor KS, Crawford C, et al Blood pressure self-monitoring in pregnancy: examining feasibility in a prospective cohort study. BMC Pregnancy Childbirth 2017; 17: 442 10.1186/s12884-017-1605-0 29284456 PMC5745883 · DOI
- [7]Hypertension in pregnancy: diagnosis and management (NICE guideline 107): National Institute for health and care excellence, 2010 Available: https://www.nice.org.uk/guidance/cg107 [Accessed 20 Nov 2018]. 31498578
- [10]Baral-Grant S, Haque MS, Nouwen A, et al Self-Monitoring of blood pressure in hypertension: a UK primary care survey. Int J Hypertens 2012; 2012: 582068 10.1155/2012/582068 22013510 PMC3195273 · DOI
- [11]Bray EP, Holder R, Mant J, et al Does self-monitoring reduce blood pressure? meta-analysis with meta-regression of randomized controlled trials. Ann Med 2010; 42: 371– 86. 10.3109/07853890.2010.489567 20504241 · DOI · Paper page
- [12]Band R, Hinton L, Tucker KL, et al Intervention planning and modification of the bump intervention: a digital intervention for the early detection of raised blood pressure in pregnancy. Pilot Feasibility Stud 2019; 5: 153 10.1186/s40814-019-0537-z 31890265 PMC6925434 · DOI
- [13]Tucker KL, Bankhead C, Hodgkinson J, et al How do home and clinic blood pressure readings compare in pregnancy? Hypertension 2018; 72: 686– 94. 10.1161/HYPERTENSIONAHA.118.10917 30354754 PMC6080884 · DOI
- [14]Chappell LC, Duckworth S, Seed PT, et al Diagnostic accuracy of placental growth factor in women with suspected preeclampsia: a prospective multicenter study. Circulation 2013; 128: 2121– 31. 10.1161/CIRCULATIONAHA.113.003215 24190934 · DOI
- [15]Cragg JG Some statistical models for limited dependent variables with application to the demand for durable goods. Econometrica 1971; 39: 829– 44. 10.2307/1909582 · DOI
- [21]Husereau D, Drummond M, Petrou S, et al Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health 2013; 16: 231– 50. 10.1016/j.jval.2013.02.002 23538175 · DOI · Paper page
- [22]Caro JJ, Briggs AH, Siebert U, et al Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--1. Value Health 2012; 15: 796– 803. 10.1016/j.jval.2012.06.012 22999128 · DOI
- [23]Jamshed S Qualitative research method-interviewing and observation. J Basic Clin Pharma 2014; 5: 87– 8. 10.4103/0976-0105.141942 PMC4194943 25316987 · DOI
- [25]Reeves S, Kuper A, Hodges BD Qualitative research methodologies: ethnography. BMJ 2008; 337: a1020 10.1136/bmj.a1020 18687725 · DOI
- [26]Hermanowicz JC The longitudinal qualitative interview. Qual Sociol 2013; 36: 189– 208. 10.1007/s11133-013-9247-7 · DOI · Paper page
- [28]Timmermans S, Berg M The practice of medical technology. Sociol Health Illn 2003; 25: 97– 114. 10.1111/1467-9566.00342 14498932 · DOI
- [29]Yardley L, Morrison L, Bradbury K, et al The person-based approach to intervention development: application to digital health-related behavior change interventions. J Med Internet Res 2015; 17: e30 10.2196/jmir.4055 25639757 PMC4327440 · DOI · Paper page
- [30]May CR, Mair FS, Dowrick CF, et al Process evaluation for complex interventions in primary care: understanding trials using the normalization process model. BMC Fam Pract 2007; 8: 42 10.1186/1471-2296-8-42 17650326 PMC1950872 · DOI · Paper page
- [31]Ziebland S, Coulter A, Calabrese JD, et al Observing interactions as an approach to understanding patients’ experiences: Understanding and using health experiences: improving patient care. Oxford Oxford University Press, 2013.
- [32]Pope C, Ziebland S, Mays N Qualitative research in health care. analysing qualitative data. BMJ 2000; 320: 114– 6. 10.1136/bmj.320.7227.114 10625273 PMC1117368 · DOI · Paper page
- [35]Horne R, Weinman J Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res 1999; 47: 555– 67. 10.1016/S0022-3999(99)00057-4 10661603 · DOI · Paper page
Cited by
Sorted by citations
Omboni, S., McManus, R. J., Bosworth, H. B., Chappell, L. C., Green, B. B., Kario, K., Logan, A. G., Magid, D. J., Mckinstry, B., Margolis, K. L., et al. (2020) · Hypertension · doi:10.1161/hypertensionaha.120.15873 · Cited by 307 · see citing works
Self-citationParati, G., Stergiou, G. S., Bilo, G., Kollias, A., Pengo, M., Ochoa, J. E., Agarwal, R., Asayama, K., Asmar, R., Burnier, M., et al. (2021) · Journal of Hypertension · doi:10.1097/hjh.0000000000002922 · Cited by 178 · see citing works
Self-citation
- Authors
- Dougall, G., Franssen, M., Tucker, K. L., Yu, L.-M., Hinton, L., Rivero-Arias, O., Abel, L., Allen, J., Band, R. J., Chisholm, A., Crawford, C., Green, M., Greenfield, S., Hodgkinson, J., Leeson, P., McCourt, C., MacKillop, L., Nickless, A., Sandall, J., Santos, M., Tarassenko, L., Velardo, C., Wilson, H., Yardley, L., Chappell, L., & McManus, R. J.
- Affiliations
- University of Oxford (GB)
- National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK
- University of Southampton (GB)
- Action on Pre-eclampsia, Evesham, UK
- University of Birmingham (GB)
- City, University of London (GB)
- NIHR Oxford Biomedical Research Centre (GB)
- King's College London (GB)
- University of Bristol (GB)
- Corresponding author
- Chappell, Lucy
- ORCID
- Dougall, Greig
- Franssen, Marloes
- Tucker, Katherine Louise
- Yu, Ly-Mee
- Hinton, Lisa
- 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
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2020-01
- Volume
- 10
- Issue
- 1
- Pages
- e034593
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC7044851
- OpenAlex
- W3001782777
- Cited by
- 47
- References
- 5
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 8 · 2023: 6 · 2022: 10 · 2021: 9 · 2020: 5 · 2019: 1
- FWCI
- 4.59
- Type
- journal article
- Language
- en
- Update notices
- correction (2020-08-27)
- Open access
- gold
- doi.org
- Locations
- BMJ Open (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
- HighWire Press Open Archive (acceptedVersion)
- City Research Online (City University London) (acceptedVersion)
- Explore Bristol Research (submittedVersion, cc-by)
- Cronfa (Swansea University) (submittedVersion, cc-by)
- Research Portal (King's College London) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by)
- Apollo (University of Cambridge) (submittedVersion, cc-by)
- Apollo (cc-by)
- Funders
- Programme Grants for Applied Research (RP-PG-0614-20005)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy and preeclampsia studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- self-measured blood pressure, hypertensive disorders of pregnancy, gestational hypertension, chronic hypertension in pregnancy, high-risk pregnancy, remote patient monitoring, systolic blood pressure, hypertension detection, maternal outcomes, perinatal outcomes, cost-effectiveness, process evaluation, patient empowerment
- MeSH terms
- Adult, Blood Pressure, Female, Follow-Up Studies, Humans, Hypertension, Pre-Eclampsia, Pregnancy, Pregnancy Complications, Cardiovascular, Prospective Studies, Quality of Life, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Telemedicine, Pregnancy, High-Risk, Blood Pressure Monitoring, Ambulatory
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
