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.

This is a Mobile-based Obstetric Monitoring for Hypertension and/or Diabetes (MOM-HD)2 program, which includes a patient-facing mobile app for uploading BP/BG data, a provider-facing web portal for viewing patient data, and biweekly tele-visits with a study nurse.

This study aims to utilize an implementation science framework to implement and comprehensively evaluate a mobile app-based perinatal telemonitoring program within real-world clinical settings. Collaborating with government and hospital stakeholders, the investigators will employ a theory-informed multi-faceted implementation strategies: (a) Train patients and family members, and provide continuous technical support (via mobile app) for at-home BP and/or BG monitoring; (b) Provide financial assistance for at-home BP and/or BG monitoring; (c) Technical assistance, audit, and feedback to the providers; and (d) Institutionalizing and sustaining the program through advisory boards at each hospital.

Study Objective and Aims

Primary Goal:

To conduct a hybrid type II effectiveness-implementation randomized controlled trial (RCT) to evaluate the impact of MOM-HD on clinical outcomes and assess its implementation in real-world settings in Nepal.

Specific aims:

• Aim 1: Assess the effectiveness of MOM-HD + standard care compared to standard care alone via a multi-center randomized controlled trial.
• Aim 2: Assess implementation outcomes of the MOM-HD using the RE-AIM framework at the patient, provider, and health system levels.
• Aim 3: Conduct a comprehensive costing analysis and economic evaluation of the MOM-HD.

Study Design

This is a type II hybrid effectiveness-implementation study conducted as a multi-site randomized controlled trial in three metropolitan hospitals in Nepal: 1) Paropakar Maternity and Women's Hospital (PMWH), 2) Dhulikhel Hospital in Dhulikhel, and 3)Nobel Medical College & Teaching Hospital in Biratnagar.

The MOM-HD telemonitoring program will consist of patient education/ training, provision of a BP monitor and/or glucometer and strips, a mobile app where BP/BG data can be uploaded, a provider-facing web portal for monitoring patient data, as well as biweekly tele-visits with a study nurse. Participants with HDP and/or GDM in the intervention group will be enrolled in the MOM-HD program from enrollment to 6 weeks postpartum.

Overall, this study aims to evaluate the effectiveness and implementation of the MOM-HD intervention, while providing insights into the costs associated with implementing the intervention in a real-world setting.

Study Duration

The study is expected to last up to 5 years. Participants will be followed from 24-30 weeks' gestation until 6 weeks postpartum.

Sample Size

A total of 864 participants (432 with HDP and 432 with GDM).

Randomization

Participants will be randomized in a 1:1 ratio to either the intervention group (MOM-HD plus standard care) or the control group (standard care alone).

Participants with both hypertensive disorders of pregnancy (HDP) and gestational diabetes mellitus (GDM) present at enrollment will be assigned to the GDM stratum for randomization and analysis. Participants who develop a second qualifying condition after enrollment will remain in their originally assigned stratum in accordance with the intention-to-treat principle. However, they will receive all applicable intervention components corresponding to their clinical diagnoses (e.g., provision of a glucometer and blood glucose monitoring for participants who develop incident GDM after enrollment). Primary analyses will be conducted according to the original stratum assignment. Sensitivity analyses will additionally evaluate outcomes among participants with dual diagnoses.

Pregnant women who meet all diagnostic and eligibility criteria but are identified at greater than 34 weeks of gestational age will not be enrolled in the RCT and will not be considered IRB study participants. However, consistent with the program's implementation objectives, these individuals will receive the intervention components and will be tracked for implementation purpose.

Study Population: See section Eligibility

Measurements

• Primary and Secondary Outcomes: See section Outcome Measures
• Implementation Outcomes: Using the RE-AIM framework (4), the study will assess Reach (e.g., proportion and characteristics of participants engaged), Adoption (provider uptake), Implementation (fidelity, facilitators, barriers), and Maintenance (sustainability and costs).

Intervention: See section Arms and Interventions

Research Method: Mixed-method and Randomized Clinical Trial

Inclusion Criteria:

• Pregnant women receiving antenatal care at RCT site

• Diagnosed with one of the following:

  • 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

• Age 18 years or older

• Access to a smartphone

• Gestational age ≤ 34 weeks at enrollment

Exclusion Criteria:

• 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)
• Declines to provide informed consent

After information that could identify the participant has been removed, de-identified information collected for this research may be shared and made publicly available as required by the National Institute of Health (NIH). The investigators will include the clinical data of those participants who provide consent for sharing their data.

Release of data will occur approximately 12 months following the end of the study. Study data will be available to the research community without end date.

The investigator will only share or make publicly available de-identified data collected for this research. The investigators will include the clinical data of those participants who provide consent for sharing their data.

The allocation sequence will be concealed from the research nurse and participants using sequentially numbered opaque sealed envelopes.