Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD): a Type II Hybrid Implementation-Effectiveness Trial - PROJECT SUMMARY Hypertensive disorders during pregnancy (HDP) and gestational diabetes (GDM) represent the foremost complications in pregnancy, significantly contributing to global maternal and fetal morbidity and mortality. Effectively managing HDP and GDM hinges on regular monitoring of blood pressure (BP) and blood glucose (BG) to ensure adequate control and timely interventions for maternal and fetal well-being. However, in low-income settings like Nepal, women encounter difficulties in making frequent healthcare visits due to logistical challenges, thereby exposing them to risks of uncontrolled BP and BG levels. Telemonitoring offers a promising and cost-effective alternative by enabling pregnant individuals to monitor BP and BG at home and share real-time results with healthcare providers, which in turn facilitates informed clinical decision-making and timely interventions. While remote monitoring has been proven effective in improving BP, BG, and perinatal outcomes among women with HDP and GDM in high-income countries, its implementation faces challenges in low-resource settings like Nepal. In our pilot study [R21TW011377-S1], we developed the MOM-HD (Mobile-based Obstetric Monitoring for Hypertension and/or Diabetes) to address pre-identified barriers by providing financial and technical assistance for patient self-monitoring of vital signs and delivering comprehensive training and technical support to healthcare providers, including developing standardized clinical algorithms and quality assurance protocols to facilitate seamless workflow. Based on promising findings from our pilot work, here we propose to conduct a Hybrid Type II Effectiveness-Implementation Randomized Controlled Trial (RCT) to assess the effectiveness and evaluate the implementation of our MOM-HD program in real-world clinical settings in Nepal. To address the study aims, we will recruit 864 women who are newly diagnosed with HDP and GDM from three metropolitan hospitals and randomly assign them to either (i) MOM-HD + standard care or (ii) standard care alone, from enrolment in pregnancy to 6 weeks postpartum. Primary and secondary clinical outcomes will be assessed at delivery, and at 6 weeks postpartum. We hypothesize that compared to standard care, the use of MOM-HD in addition to standard care will result in lower systolic BP levels, lower incidence rate for the composite adverse perinatal outcome of either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery or labor induction, and lower proportion of days with elevated systolic BP or BG readings between recruitment and 6 weeks postpartum. A convergent mixed-methods approach will be used to assess implementation and maintenance outcomes using the RE-AIM framework, and economic sustainability will be assessed by collecting primary cost data. If successful, the study would yield effective implementation strategies to implement a mobile-based telemonitoring program and enhance clinical management and outcomes among pregnant women with HDP and GDM in other low-resource countries. Findings from this study will also develop the knowledge, tools and processes needed to broadly disseminate and scale evidence-based telemonitoring interventions for HDP and GDM in diverse settings.
