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Blood Pressure Monitoring in High Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-034593 on 23 January 2020. Downloaded from 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 ,1 Marloes Franssen,1 Katherine Louise Tucker ,1 Ly- Mee Yu,1 Lisa Hinton ,1 Oliver Rivero- Arias,2 Lucy Abel,1 Julie Allen,1 Rebecca Jane Band ,3 Alison Chisholm,1 Carole Crawford,1 Marcus Green,4 Sheila Greenfield,5 James Hodgkinson,5 Paul Leeson,6 Christine McCourt,7 Lucy MacKillop ,8 Alecia Nickless,1 Jane Sandall,9 Mauro Santos,10 Lionel Tarassenko,10 Carmelo Velardo,10 Hannah Wilson,9 Lucy Yardley,3,11 Lucy Chappell,9 Richard J McManus 1 To cite: Dougall G, Franssen M, ABSTRACT Strengths and limitations of this study Tucker KL, et al. Blood Introduction Self- monitoring of blood pressure (BP) in pressure monitoring in high- pregnancy could improve the detection and management ► Based on current literature, these will be the largest risk pregnancy to improve of pregnancy hypertension, while also empowering and the detection and monitoring randomised controlled trials of blood pressure self- engaging women in their own care. Two linked trials aim of hypertension (the BUMP monitoring in pregnancy completed to date. to evaluate whether BP self- monitoring in pregnancy 1 and 2 trials): protocol ► The pragmatic trial designs, with broad inclusion improves the detection of raised BP during higher risk for two linked randomised criteria, will make findings of both linked studies pregnancies (BUMP 1) and whether self- monitoring controlled trials. BMJ Open applicable to routine antenatal care. 2020;10:e034593. doi:10.1136/ reduces systolic BP during hypertensive pregnancy (BUMP ► Data on the correct targets for self- monitored blood bmjopen-2019-034593 2). pressure are currently sparse. http://bmjopen.bmj.com/ Methods and analyses Both are multicentre, non- ► Prepublication history for ► The trials are powered for primary and some sec- masked, parallel group, randomised controlled trials. this paper is available online. ondary outcomes but the effect of self-monitoring Participants will be randomised to self- monitoring To view these files, please visit on rarer secondary maternal morbidity and mortality with telemonitoring or usual care. BUMP 1 will recruit the journal online (http:// dx. doi. outcomes will still be uncertain. org/ 10. 1136/ bmjopen- 2019- a minimum of 2262 pregnant women at higher risk ► Women with gestational hypertension may develop 034593). of pregnancy hypertension and BUMP 2 will recruit a this late in pregnancy making it harder to show ben- minimum of 512 pregnant women with either gestational efit for interventions at this time. GD and MF are joint first or chronic hypertension. The BUMP 1 primary outcome is authors. the time to the first recording of raised BP by a healthcare on September 26, 2021 by guest. Protected copyright. LC and RJM are joint senior professional. The BUMP 2 primary outcome is mean authors. systolic BP between baseline and delivery recorded by Trial registration number NCT03334149 Received 27 September 2019 healthcare professionals. Other outcomes will include Revised 20 December 2019 maternal and perinatal outcomes, quality of life and Accepted 30 December 2019 adverse events. An economic evaluation of BP self- monitoring in addition to usual care compared with usual INTRODUCTION care alone will be assessed across both study populations Raised blood pressure (BP) affects approxi- within trial and with modelling to estimate long- term cost- mately 10% of pregnancies worldwide, almost effectiveness. A linked process evaluation will combine half of these women develop pre-eclampsia. 1 quantitative and qualitative data to examine how BP self- Globally, around 15% of maternal mortality is © Author(s) (or their monitoring in pregnancy is implemented and accepted in employer(s)) 2020. Re- use due to pre- eclampsia so early detection and both daily life and routine clinical practice. 2 permitted under CC BY. prevention are paramount. In the UK, inade- Ethics and dissemination The trials have been approved Published by BMJ. quate management of raised BP, in particular by a Research Ethics Committee (17/WM/0241) and For numbered affiliations see relevant research authorities. They will be published in systolic hypertension, has previously been end of article. peer- reviewed journals and presented at national and reported as a significant contributing factor Correspondence to international conferences. If shown to be effective, BP to maternal deaths and although this has Professor Lucy Chappell; self- monitoring would be applicable to a large population improved over the past decade, pre- eclampsia lucy. chappell@ kcl. ac. uk of pregnant women. remains important.3 4 Dougall G, et al. BMJ Open 2020;10:e034593. doi:10.1136/bmjopen-2019-034593 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-034593 on 23 January 2020. Downloaded from BP self-monitoring, where an individual measures their control in women with hypertensive pregnancy (BUMP own BP outside of the clinical setting, allows for multiple 2). measurements providing a better estimate of the under- lying BP than intermittent clinic measurements. Such self- monitoring in pregnancy could improve both the METHODS AND ANALYSIS detection and subsequent management of gestational Study design and setting hypertensive disorders including pre- eclampsia, while The BUMP trials are two linked, multicentre, non- also empowering and engaging women in their own masked, parallel group, randomised controlled trials care.5 6 investigating self- monitoring of BP during pregnancy in Women who are at higher risk for raised BP in preg- the UK in secondary care maternity units (sites listed on nancy (eg, due to age or previous medical history) https:// clinicaltrials. gov/ ct2/ show/ NCT03334149). The may require more frequent monitoring.7 8 BP can rise work is part of a larger programme of work investigating rapidly in pregnancy and hypertension may go unde- the use of self- monitoring and testing during pregnancy. tected in between antenatal visits.2 Once raised BP is The BUMP 1 trial is a prospective non- masked detected during the pregnancy, the clinical focus is on randomised controlled trial of self-monitoring of BP treating the hypertension, monitoring for development in pregnancy for the detection of raised BP. Women at of pre- eclampsia and ensuring appropriate fetal surveil- higher risk of pre-eclampsia will be recruited through lance.7 Substantial resources are currently expended in antenatal clinics. The consent process for BUMP 1 will include discussion of the transition to BUMP 2 should a monitoring such women, from the perspective of both woman develop raised BP. the woman and the National Health Service (NHS).9 If The BUMP 2 trial is a prospective non- masked shown to be successful, self- monitoring could provide randomised controlled trial of self-monitoring of BP for more accurate data for clinicians to use for treatment the management of hypertension in pregnancy in women and management strategies, safely reduce the burden of with chronic hypertension (CH) or gestational hyperten- multiple clinic visits for women, free up time for midwives sion (GH). Women may enter this study from BUMP 1 and therefore be a cost- effective option. Self- monitoring (maintaining original randomisation) or be recruited is easy to accomplish and is now commonplace in adults 10 11 without prior involvement. See figure 1 for an overview with hypertension outside of pregnancy. of the study design. BP self-monitoring is, therefore, a potentially appealing There will be an initial external pilot phase including option for both the detection and management of hyper- up to 50 women in order to test trial procedures prior to tension. We have previously shown feasibility and accept- the commencement of full recruitment. ability of self-monitoring of BP in pregnancy.5 6 This trial aims to investigate self- monitoring in two groups Intervention and controls groups http://bmjopen.bmj.com/ by undertaking two linked, parallel group, randomised Usual care trials to evaluate whether self-monitoring of BP improves Usual care will consist of pregnant women having their the detection of raised BP during higher risk pregnan- BP measured by their usual antenatal care team, and cies (BUMP 1) and whether self- monitoring improves BP initiation and/or adjustment of medication (where on September 26, 2021 by guest. Protected copyright. Figure 1 Study design. BUMP 1, BP during higher risk pregnancy; CH, chronic hypertension; GH, gestational hypertension; HT, hypertension; NT, normotension. 2 Dougall G, et al. BMJ Open 2020;10:e034593. doi:10.1136/bmjopen-2019-034593 Open access BMJ Open: first published as 10.1136/bmjopen-2019-034593 on 23 January 2020. Downloaded from appropriate) based on these measurements at the discre- Department of Engineering Science, and appropriate tion of the healthcare professional. functionality testing was done by the development team to test different combinations of normal and abnormal Self-monitoring BP readings and user behaviours (eg, poor adherence Women randomised to self-monitoring will be provided or numerous, unrequested readings) over a prolonged with a monitor validated for use in pregnancy and pre- period followed by user testing with pregnant women.6 12 eclampsia (Microlife WatchBP Home) and instructions BUMP 1 participants will be asked to monitor their BP for its use. Participants will be enrolled on the telemon- itoring system, a text/app- based system and provided three times a week throughout their pregnancy. They will with clear instructions on its use. Participants can switch be instructed to sit quietly and comfortably for 1 min, take between the text and app system to decrease problems two readings 1 min apart and submit their second reading with connectivity for example, poor internet connection to the telemonitoring system. Participants will receive a or phone signal. Access to the telemonitoring system was guideline with colour- coded instructions (figure 2).
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