Key result
The Heart4U mobile health application's efficacy in reducing systolic blood pressure among 580 pregnant individuals with hypertensive disorders of pregnancy will be evaluated in a planned trial.
Why the study?
Hypertensive disorders of pregnancy (HDP) carry significant maternal and fetal risks, yet management is complicated by fetal safety concerns regarding pharmacotherapy. Mobile health applications show promise for blood pressure management in this population.
Does the Heart4U mHealth application reduce systolic blood pressure in pregnant individuals with or at high risk for hypertensive disorders of pregnancy?
RCT (n=580)
Open-label
1:1 ratio, stratified by pre-existing use of antihypertensive medication
No
Does the Heart4U mHealth application reduce systolic blood pressure in pregnant individuals with or at high risk for hypertensive disorders of pregnancy?
Answers are grounded in this paper and cite their sources.
This study protocol outlines a randomized controlled trial to evaluate whether a mobile health application can improve blood pressure management in pregnant individuals with or at high risk for hypertensive disorders of pregnancy.
Background Hypertensive disorders of pregnancy (HDP) pose significant risks to both maternal and fetal health, contributing to global morbidity and mortality. Management of HDP is complex, particularly because of concerns regarding fetal safety associated with pharmaceutical interventions. The use of mobile health (mHealth) applications for blood pressure management has shown promise. This prospective study aims to evaluate the efficacy of the Heart4U mHealth application for proactive blood pressure management in pregnant individuals with HDP, to improve short-term maternal and fetal outcomes and potential long-term cardiovascular consequences. Methods This prospective, randomized, single-center trial will include 580 pregnant participants who meet the HDP criteria or who have a heightened risk of pregnancy-related hypertension due to factors such as multiple pregnancies, obesity, diabetes, or a history of HDP in prior pregnancies leading to preterm birth. Participants are randomized to either the mHealth intervention group or the standard care group. The primary endpoint is the difference in systolic blood pressure from enrollment to one month after childbirth. The secondary endpoints include various blood pressure parameters, obstetric outcomes, body mass index trajectory, step counts, mood assessment, and drug adherence. Conclusions This study emphasizes the potential of mHealth interventions, such as the Heart4U application, to improve blood pressure management in pregnant individuals with HDP. By leveraging technology to enhance engagement, communication, and monitoring, this study aims to positively impact maternal, fetal, and postpartum outcomes associated with HDP. This innovative approach demonstrates the potential of personalized technology-driven solutions for managing complex health conditions. Trial registration: ClinicalTrials.gov (NCT05995106) registered in 16 August 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05995106
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Kwun et al. (2023) conducted an RCT in Hypertensive disorders of pregnancy (n=580). Heart4U mobile health application vs. Standard care was evaluated on Difference in systolic blood pressure from enrollment to 1 month after childbirth. The Heart4U mobile health application's efficacy in reducing systolic blood pressure among 580 pregnant individuals with hypertensive disorders of pregnancy will be evaluated in a planned trial.
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