Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial.
Tucker KL., Mort S., Yu L-M., Campbell H., Rivero-Arias O., Wilson HM., Allen J., Band R., Chisholm A., Crawford C., Dougall G., Engonidou L., Franssen M., Green M., Greenfield S., Hinton L., Hodgkinson J., Lavallee L., Leeson P., McCourt C., Mackillop L., Sandall J., Santos M., Tarassenko L., Velardo C., Yardley L., Chappell LC., McManus RJ., BUMP Investigators None.
ImportanceInadequate 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.ObjectiveTo determine whether self-monitoring of BP in higher-risk pregnancies leads to earlier detection of pregnancy hypertension.Design, setting, and participantsUnblinded, 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.InterventionsParticipating 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 measuresThe primary outcome was time to first recorded hypertension measured by a health care professional.ResultsAmong 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 relevanceAmong 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 registrationClinicalTrials.gov Identifier: NCT03334149.