Lucy C Chappell1, Katherine L Tucker2, Ushma Galal2, Ly-Mee Yu2, Helen Campbell3, Oliver Rivero-Arias3, Julie Allen2, Rebecca Band4, Alison Chisholm2, Carole Crawford2, Greig Dougall2, Lazarina Engonidou2, Marloes Franssen2, Marcus Green5, Sheila Greenfield6, Lisa Hinton7, James Hodgkinson6, Layla Lavallee2, Paul Leeson8, Christine McCourt9, Lucy Mackillop10, Jane Sandall1, Mauro Santos11, Lionel Tarassenko11, Carmelo Velardo11, Hannah Wilson1, Lucy Yardley4,12, Richard J McManus2. 1. Department of Women and Children's Health, King's College London, London, United Kingdom. 2. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom. 3. National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, 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, 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 & 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 is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective: To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Interventions: Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures: The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results: Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance: Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.
Importance: Inadequate management of elevated blood pressure is a significant contributing factor to maternal deaths. The role of blood pressure self-monitoring in pregnancy in improving clinical outcomes for the pregnant individual and infant is unclear. Objective: To evaluate the effect of blood pressure self-monitoring, compared with usual care alone, on blood pressure control and other related maternal and infant outcomes, in individuals with pregnancy hypertension. Design, Setting, and Participants: Unblinded, randomized clinical trial that recruited between November 2018 and September 2019 in 15 hospital maternity units in England. Individuals with chronic hypertension (enrolled up to 37 weeks' gestation) or with gestational hypertension (enrolled between 20 and 37 weeks' gestation). Final follow-up was in May 2020. Interventions: Participants were randomized to either blood pressure self-monitoring using a validated monitor and a secure telemonitoring system in addition to usual care (n = 430) or to usual care alone (n = 420). Usual care comprised blood pressure measured by health care professionals at regular antenatal clinics. Main Outcomes and Measures: The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth. Results: Among 454 participants with chronic hypertension (mean age, 36 years; mean gestation at entry, 20 weeks) and 396 with gestational hypertension (mean age, 34 years; mean gestation at entry, 33 weeks) who were randomized, primary outcome data were available from 444 (97.8%) and 377 (95.2%), respectively. In the chronic hypertension cohort, there was no statistically significant difference in mean systolic blood pressure for the self-monitoring groups vs the usual care group (133.8 mm Hg vs 133.6 mm Hg, respectively; adjusted mean difference, 0.03 mm Hg [95% CI, -1.73 to 1.79]). In the gestational hypertension cohort, there was also no significant difference in mean systolic blood pressure (137.6 mm Hg compared with 137.2 mm Hg; adjusted mean difference, -0.03 mm Hg [95% CI, -2.29 to 2.24]). There were 8 serious adverse events in the self-monitoring group (4 in each cohort) and 3 in the usual care group (2 in the chronic hypertension cohort and 1 in the gestational hypertension cohort). Conclusions and Relevance: Among pregnant individuals with chronic or gestational hypertension, blood pressure self-monitoring with telemonitoring, compared with usual care, did not lead to significantly improved clinic-based blood pressure control. Trial Registration: ClinicalTrials.gov Identifier: NCT03334149.
Authors: Katherine L Tucker; Kathryn S Taylor; Carole Crawford; James A Hodgkinson; Clare Bankhead; Tricia Carver; Elizabeth Ewers; Margaret Glogowska; Sheila M Greenfield; Lucy Ingram; Lisa Hinton; Khalid S Khan; Louise Locock; Lucy Mackillop; Christine McCourt; Alexander M Pirie; Richard Stevens; Richard J McManus Journal: BMC Pregnancy Childbirth Date: 2017-12-28 Impact factor: 3.007
Authors: Danielle C Ashworth; Sophie P Maule; Fiona Stewart; Hannah L Nathan; Andrew H Shennan; Lucy C Chappell Journal: Cochrane Database Syst Rev Date: 2020-07-23
Authors: Laura A Magee; Peter von Dadelszen; Joel Singer; Terry Lee; Evelyne Rey; Susan Ross; Elizabeth Asztalos; Kellie E Murphy; Jennifer Menzies; Johanna Sanchez; Amiram Gafni; Michael Helewa; Eileen Hutton; Gideon Koren; Shoo K Lee; Alexander G Logan; Wessel Ganzevoort; Ross Welch; Jim G Thornton; Jean-Marie Moutquin Journal: Hypertension Date: 2016-09-12 Impact factor: 10.190
Authors: Joy E Lawn; Hannah Blencowe; Peter Waiswa; Agbessi Amouzou; Colin Mathers; Dan Hogan; Vicki Flenady; J Frederik Frøen; Zeshan U Qureshi; Claire Calderwood; Suhail Shiekh; Fiorella Bianchi Jassir; Danzhen You; Elizabeth M McClure; Matthews Mathai; Simon Cousens Journal: Lancet Date: 2016-01-19 Impact factor: 79.321
Authors: Eunjung Choi; Brigitte Kazzi; Bhavya Varma; Alexandra R Ortengren; Anum S Minhas; Arthur Jason Vaught; Wendy L Bennett; Jennifer Lewey; Erin D Michos Journal: Curr Cardiovasc Risk Rep Date: 2022-09-21