Question: Does self-monitoring of blood pressure by pregnant individuals at higher risk of preeclampsia lead to earlier detection of pregnancy hypertension compared to usual antenatal care? Findings: In this randomized clinical trial that included 2441 pregnant individuals at increased risk for pre-eclampsia, use of self-monitoring of BP with telemonitoring compared with usual care resulted in a mean time to clinic-based detection of hypertension of 104 vs 106 days, a difference that was not statistically significant.Meaning: Among pregnant individuals at higher risk of pre-eclampsia, blood pressure selfmonitoring with telemonitoring did not lead to earlier clinic-based detection of hypertension.
IntroductionSelf-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).Methods and analysesBoth are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice.Ethics and disseminationThe trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women.Trial registration numberNCT03334149
(Abstracted from JAMA 2022;327:1656–1665It is estimated that approximately 10% of pregnancies worldwide in 2019 were affected by elevated blood pressure (BP). The United Kingdom has previously reported inadequate monitoring of elevated BP as a significant contributing factor to maternal death.
Study designMulticentre, double-blind, placebo-controlled randomised clinical trial.ObjectivesTo compare the effectiveness of long chain omega-3 polyunsaturated fatty acids (PUFAs) as part of the management for people diagnosed with rotator cuff related shoulder pain (RCRSP).Summary of backgroundAlthough there is no robust evidence to support their use, omega-3 PUFAs have been recommended for those with tendinopathy due to their potential to moderate inflammation.MethodsParticipants with RCRSP (n=73) were randomised to take either nine MaxEPA capsules providing 1.53 g eicosapentaenoic acid, 1.04 g docosahexaenoic acid or nine matching placebo capsules containing oleic acid per day for 8 weeks. In addition, participants attended an exercise/education programme for 8 weeks. Participants were assessed at prerandomisation, 8 weeks (primary outcome point), 3 months, 6 months and 12 months (secondary outcome point). Primary outcome was the Oxford Shoulder Score (OSS). Secondary outcomes included the Shoulder Pain and Disability Index (SPADI), Patient Specific Functional Score, Euro Qol 5D-3L, Short Form 36, global rating of change and impairment measurements. Analysis was by intention to treat.ResultsDifference in the change in the OSS between the two groups at 2 months was –0.1 (95% CI −2.6 to 2.5, p=0.95). The change in SPADI scores was −8.3 (95% CI −15.6 to −0.94, p=0.03, analysed by analysis of covariance adjusted for baseline) at 3 months.Conclusion Omega-3 PUFA supplementation may have a modest effect on disability and pain outcomes in RCRSP.
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