Katherine L Tucker1, Sam Mort1, Ly-Mee Yu1, Helen Campbell2, Oliver Rivero-Arias2, Hannah M Wilson3, Julie Allen1, Rebecca Band4, Alison Chisholm1, Carole Crawford1, Greig Dougall1, Lazarina Engonidou1, Marloes Franssen1, Marcus Green5, Sheila Greenfield6, Lisa Hinton1,7, James Hodgkinson6, Layla Lavallee1, Paul Leeson8, Christine McCourt9, Lucy Mackillop10, Jane Sandall3, Mauro Santos11, Lionel Tarassenko11, Carmelo Velardo11, Lucy Yardley4,12, Lucy C Chappell3, Richard J McManus1. 1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom. 2. National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom. 3. Department of Women and Children's Health, King's College London, St Thomas' Hospital, London, United Kingdom. 4. Department of Psychology, University of Southampton, Southampton, United Kingdom. 5. Action on Pre-eclampsia, The Stables, Evesham, Worcestershire, United Kingdom. 6. Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom. 7. The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, United Kingdom. 8. Cardiovascular Clinical Research Facility, RDM Division of Cardiovascular Medicine, University of Oxford, Oxford, United Kingdom. 9. Centre for Maternal and Child Health Research, City, University of London, London, United Kingdom. 10. Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, United Kingdom. 11. Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford, Oxford, United Kingdom. 12. School of Psychological Science, University of Bristol, Bristol, United Kingdom.
Abstract
Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.
Importance: Inadequate management of elevated blood pressure (BP) is a significant contributing factor to maternal deaths. Self-monitoring of BP in the general population has been shown to improve the diagnosis and management of hypertension; however, little is known about its use in pregnancy. Objective: To determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that included 2441 pregnant individuals at higher risk of preeclampsia and recruited at a mean of 20 weeks' gestation from 15 hospital maternity units in England between November 2018 and October 2019. Final follow-up was completed in April 2020. Interventions: Participating individuals were randomized to either BP self-monitoring with telemonitoring (n = 1223) plus usual care or usual antenatal care alone (n = 1218) without access to telemonitored BP. Main Outcomes and Measures: The primary outcome was time to first recorded hypertension measured by a health care professional. Results: Among 2441 participants who were randomized (mean [SD] age, 33 [5.6] years; mean gestation, 20 [1.6] weeks), 2346 (96%) completed the trial. The time from randomization to clinic recording of hypertension was not significantly different between individuals in the self-monitoring group (mean [SD], 104.3 [32.6] days) vs in the usual care group (mean [SD], 106.2 [32.0] days) (mean difference, -1.6 days [95% CI, -8.1 to 4.9]; P = .64). Eighteen serious adverse events were reported during the trial with none judged as related to the intervention (12 [1%] in the self-monitoring group vs 6 [0.5%] in the usual care group). Conclusions and Relevance: Among pregnant individuals at higher risk of preeclampsia, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly earlier clinic-based detection of hypertension. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.
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