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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
  1. Greig Dougall1,
  2. Marloes Franssen1,
  3. Katherine Louise Tucker1,
  4. Ly-Mee Yu1,
  5. Lisa Hinton1,
  6. Oliver Rivero-Arias2,
  7. Lucy Abel1,
  8. Julie Allen1,
  9. Rebecca Jane Band3,
  10. Alison Chisholm1,
  11. Carole Crawford1,
  12. Marcus Green4,
  13. Sheila Greenfield5,
  14. James Hodgkinson5,
  15. Paul Leeson6,
  16. Christine McCourt7,
  17. Lucy MacKillop8,
  18. Alecia Nickless1,
  19. Jane Sandall9,
  20. Mauro Santos10,
  21. Lionel Tarassenko10,
  22. Carmelo Velardo10,
  23. Hannah Wilson9,
  24. Lucy Yardley3,11,
  25. Lucy Chappell9,
  26. Richard J McManus1
  1. 1Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  2. 2National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK
  3. 3Academic Unit of Psychology, University of Southampton, Southampton, UK
  4. 4Action on Pre-eclampsia, Evesham, UK
  5. 5Primary Care Clinical Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  6. 6Cardiovascular Clinical Research Facility, Division of Cardiovascular Medicine, University of Oxford, Oxford, UK
  7. 7Centre for Maternal & Child Health Research, School of Health Sciences, City University, London, UK
  8. 8NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
  9. 9Department of Women and Children's Health, Kings College, London, London, UK
  10. 10Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, UK
  11. 11School of Psychological Science, University of Bristol, Bristol, UK
  1. Correspondence to Professor Lucy Chappell; lucy.chappell{at}kcl.ac.uk

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 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

  • pregnancy
  • gestational hypertension
  • pre-eclampsia
  • hypertension
  • self-monitoring
  • blood pressure
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Footnotes

  • GD and MF are joint first authors.

  • LC and RJM are joint senior authors.

  • Twitter @2dvisio

  • Contributors RJM had the original idea and applied for funding with KLT, LC, L-MY, LH, OR-A, CC, MG, SG, JH, PL, CM, LM, JS, LT and LY. MF, GD, RJM, LC and KLT wrote the first draft. AN and L-MY provided the sample size calculations and statistical analysis section. RJM, KLT, LH, RJB, LY, MS and CV worked on developing the intervention. CC and HW are coordinating research midwives. LH and AC provided the qualitative section. OR-A and LA provided the economic evaluation section. GD is the trial manager (previously MF) and JA is the senior trial manager. All authors subsequently critically edited the manuscript. RJM will be guarantor for the manuscript. All authors have read and approved the final manuscript.

  • Funding 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.

  • Disclaimer The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and social care.

  • Competing interests RJM has previously received BP monitors from Omron for research purposes. The BP monitors for the current trials were purchased from the manufacturer (Microlife) at commercial prices.

  • Patient consent for publication Not required.

  • Ethics approval The protocol, informed consent form, participant information sheet and all other participant-facing material have been approved by the Research Ethics Committee (West Midlands - South Birmingham: ref 17/WM/0241), host institution(s) and Health Research Authority.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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