作者
Lucy C. Chappell,Katherine L. Tucker,Ushma Galal,Ly‐Mee Yu,Helen Campbell,Oliver Rivero‐Arias,Julie Allen,Rebecca Band,Alison Chisholm,Carole Crawford,Greig Dougall,Lazarina Engonidou,Marloes Franssen,Marcus Green,Sheila Greenfield,Lisa Hinton,James Hodgkinson,Layla Lavallee,Paul Leeson,Christine McCourt,Lucy Mackillop,Jane Sandall,Mauro Santos,Lionel Tarassenko,Carmelo Velardo,Hannah Wilson,Lucy Yardley,Richard J. McManus,Johanna Cook,Maria Coates,Gabriel Thomas,Stephanie Brann,Joris De Henau,Sadie Kelly,Dave Watt,David Judge,Luis Castello,Tabitha Wishlade,Helen P. Price,Eleni Fotaki,Zoë Vowles,Alice Lewin,Hayley Tarft,Julie Wade,Declan Symington,Jessamine Hunt,Maria Slaney,Charlotte Mungeam,Rehan Ullah Khan,Amy Thomas,Tabitha Newman,Melanie Gouldbourne,Alexandra Keen,Alice S. Rossi,Zandile Maseko,David Churchill,Laura Devison,Kayleigh Brooks,Julia Icke,Patrick Bose,Fidelma Lee,Suzanne Scanlon,Joanna Girling,Mark R. Johnson,Natasha Singh,Carmela Martella,Christine Adamson,Maria Sogo Buaki,Nikki Beadle,Harriet Hickey,Amanda Iriondo-Coysh,Joanna Chilvers,Daisy Duncan,Miriam Bourke,Jenny Myers,Natalie Barry,Heather Glossop,Kimberley Farrant,Clare Waters,Sujatha Thamban,Prudence Jones,Sophia Felippe,Nikos A. Kametas,Polly Kay,Katherine Clark,Rebecca Jarman,Olivia Snowball,Hayley Martin,Osaeloke Osakwe,Bernadette Tilley,Any Barker,Raquel González,Asma Khalil,Sophie Robinson,Lisa Canclini,Rebecca Unwin,Katie Morris,Dianne Mellers,Phern Adams,Lesley Brittain,Sohpie Dann,Chloe O'Hara,Diane Whitehouse,Bini Ajay,Geraldine Upson,Hannah O’Donnell,Maria Zammit-Mangion,Julie Tebbutt,Lisa Frankland,Danielle Thornton,Kristina Sexton,Rebecca Crowe,Amy Bowers,Joanne Winterbottom
摘要
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.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.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.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.The primary maternal outcome was the difference in mean systolic blood pressure recorded by health care professionals between randomization and birth.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).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.ClinicalTrials.gov Identifier: NCT03334149.