Hypertensive disorders during pregnancy (HDP) and gestational diabetes (GDM) are among the leading complications in pregnancy, significantly contributing to global maternal and fetal morbidity and mortality. (1,2,3) Effective management of 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. 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, facilitating informed clinical decision-making and timely interventions.
Here the investigators propose to conduct a Hybrid Type II Effectiveness-Implementation Randomized Controlled Trial (RCT) to assess the effectiveness and evaluate the implementation of the MOM-HD (Mobile-based Obstetric Monitoring for Hypertension and/or Diabetes) program, a mobile app-based perinatal telemonitoring program, in real-world clinical settings in Nepal. To address the study aims, the investigators 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. The investigators 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 (4), and economic sustainability will be assessed by collecting primary cost data.
Pregnant women receiving antenatal care at RCT site
Chronic hypertension (sustained systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg, or on antihypertensive treatment before 20 weeks of gestation)
Gestational hypertension or preeclampsia without severe features (sustained systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg after 20 weeks of gestation)
Gestational diabetes
Multifetal pregnancies
Apparent communication difficulties (e.g., hearing, speech, or cognitive impairments), as judged by research assistants
Unable to understand the Nepali language
Severe maternal illness or any condition that precludes active study participation (e.g., preeclampsia with severe features, eclampsia, HELLP syndrome, or other conditions requiring inpatient management)
Parallel
MOM-HD
BehavioralParticipants will receive education and training on proper BP and/or BG monitoring and will be provided a BP monitor and/or glucometer with strips. They will be asked to use the MOM-HD mobile app to measure and record daily BP (until 6 weeks postpartum) and, for women with GDM, fasting and 2-hour postprandial BG (until delivery). Readings are automatically uploaded via Bluetooth to a provider portal and reviewed daily by a nurse. Participants will receive automated reminders, instant feedback on readings, and educational materials via the app. They will participate in biweekly tele-visits with a nurse to review readings, discuss symptoms, and receive counseling on lifestyle, diet, and care plans.
Standard Care
Other interventionPregnant women with HDP and GDM will receive standard antenatal care, which includes more frequent hospital visits (6-8 extra), ultrasound, urine dipstick, BP/BG monitoring with paper record booklets, dietary and physical activity counseling, and OB/GYN follow-up. GDM patients will consult with a dietitian and physical therapist. Postpartum follow-up includes BP/BG testing at 6 weeks.
Mean systolic BP from recruitment to delivery (continuous)
Difference in mean systolic blood pressure between usual care and intervention group
Rate of composite adverse perinatal outcome (categorical; either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery, preterm birth )
Perinatal loss, neonatal intensive care unit admission, primary cesarean delivery, preterm birth will be abstracted from medical records.
Proportion of days with elevated blood pressure (BP) or blood glucose (BG) readings (above clinical target ranges) between recruitment and delivery (continuous)
Proportion of days with elevated BP or BG readings (out of total number of days with valid measurements) will be compared between the usual care and intervention group
Mean diastolic BP from recruitment to delivery (continuous)
Mean diastolic BP levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and/or medical records (hospital measurements).
Mean diastolic BP at 6 week postpartum (continuous)
Difference in diastolic BP between usual care and intervention group
Mean fasting BG levels from recruitment to delivery (continuous; only among women with GDM)
Mean BG levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and/or medical records (hospital measurements).
Mean postprandial BG levels from recruitment to delivery (continuous; only among women with GDM)
Mean BG levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and/or medical records (hospital measurements).
App usage (Intervention group only)
The MOM-HD app will keep a usage record for each of the individual app feature(s) used (e.g., BP/BG), time of day the app/feature was used, and time spent in each feature.
App compliance ( Intervention group only)
Self-monitoring frequency data, such as the number of BP/BG entries in the app over the entire monitoring period, will be recorded for each participant in the intervention group. This is the actual number of app entries divided by the expected app entries multiplied by 100).
Usability ( Intervention group only)
The System Usability Scale, (5) a 10-item 5-point Likert scale questionnaire will be administered to assess the perceived usability of the MOM-HD app.
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Rutgers, The State University of New Jersey
Lead sponsor
Dhulikhel Hospital
Collaborator
Institute for Implementation Science and Health
Collaborator