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Gestational Diabetes / Hypertensive Disorder of Pregnancy / MOM-HD · Interventional Study
ClinicalTrials.gov · July 31, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Hybrid Type II RCT evaluating a mobile app-based telemonitoring program (MOM-HD) for pregnant women with hypertensive disorders and/or gestational diabetes in Nepal. No results have been posted; recruitment is ongoing and outcomes will be assessed at delivery and 6 weeks postpartum.
Interventional, Randomized, Parallel, Open label, Supportive Care purpose. Gestational Diabetes, Hypertensive Disorder of Pregnancy; Female; age from 18 Years. Intervention: MOM-HD Intervention Group. Compared with: Standard Care Group — Active Comparator. n = 864. 3 sites: Nepal.
This is a planned Hybrid Type II RCT evaluating a mobile app-based telemonitoring program (MOM-HD) for pregnant women with hypertensive disorders and/or gestational diabetes in Nepal. No results have been posted; recruitment is ongoing and outcomes will be assessed at delivery and 6 weeks postpartum.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results from this trial will inform whether mobile-based telemonitoring integrated with standard care improves blood pressure and glucose control and reduces adverse perinatal outcomes in low-resource settings. Findings may guide implementation and sustainability of remote monitoring in similar contexts.
This is a clinical trial registry record describing a planned Hybrid Type II effectiveness-implementation RCT with no results yet reported; enrollment is ongoing and outcomes have not been assessed.
As stated by the source record.
Quoted from the source exactly as published.
Results from this trial will inform whether mobile-based telemonitoring integrated with standard care improves blood pressure and glucose control and reduces adverse perinatal outcomes in low-resource settings. Findings may guide implementation and sustainability of remote monitoring in similar contexts.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07243886). This is a study registration, not published results. Lead sponsor: Rutgers, The State University of New Jersey. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 864 participants (ESTIMATED). Conditions: Gestational Diabetes, Hypertensive Disorder of Pregnancy. Interventions: BEHAVIORAL: MOM-HD; OTHER: Standard Care. Primary outcome measures: Mean systolic BP from recruitment to delivery (continuous) , Post-treatment (at delivery); Rate of composite adverse perinatal outcome (categorical; either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery, preterm birth ) , Post-treatment (at delivery); Proportion of days with elevated blood pressure (BP) or blood glucose (BG) readings (above clinical target ranges) between recruitment and delivery (continuous) , Post-treatment (at delivery). Brief summary: 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.
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