Prospective validation of a mobile health application for blood pressure management in patients with hypertensive disorders of pregnancy: study protocol for a randomized controlled trial.

Abstract 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