An interventional study of MOM-HD and Standard Care in Gestational Diabetes and Hypertensive Disorder of Pregnancy, sponsored by Rutgers, The State University of New Jersey. Recruiting at 3 sites in Nepal. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Supportive care
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:
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
Intervention: See section Arms and Interventions
Research Method: Mixed-method and Randomized Clinical Trial
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 864 is above the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to standard care, participants in the intervention group will use the MOM-HD telemonitoring program, which includes patient education, a blood pressure (BP) monitor and/or glucometer, and a mobile app for uploading daily BP/blood glucose (BG) readings. Women with GDM will receive both devices; those with HDP will receive a BP monitor. The MOM-HD app transfers readings via Bluetooth, provides reminders for BP/BG testing, and allows providers to review data through a secure portal. Nurses will conduct biweekly tele-visits to review results, address concerns, and connect patients with OB/GYNs or dieticians as needed. The goal is to improve self-monitoring, patient-provider communication, and timely clinical decision-making, ultimately enhancing maternal and neonatal outcomes. Both groups continue standard antenatal care, with MOM-HD designed to evaluate the added benefit of telemonitoring.
Behavioral: MOM-HD
In standard care, pregnant women with HDP and GDM are required to attend hospitals more frequently than the usual antenatal schedule, typically adding 6-8 extra visits for closer monitoring. The maternal-fetal medicine specialist customizes the follow-up schedule, often requiring visits every two weeks until 35 weeks, then weekly. During these visits, patients undergo tests such as ultrasounds, urine dipsticks for proteinuria, and BP/BG monitoring, with results recorded in paper booklets assigned to each patient. Additionally, women are encouraged to regularly monitor their BP and/or BG (fasting and 2-hour post-prandial) at home or at the nearest health post. GDM patients also consult a dietitian and physical therapist to develop a personalized diet and exercise plan based on pre-pregnancy weight and disease severity. OB/GYN physicians monitor BP/BG levels and adjust medications accordingly. Follow-up BP/BG testing is conducted six weeks postpartum.
Other: Standard Care
Participants 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.
Pregnant 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
Time frame: Post-treatment (at delivery)
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.
Time frame: 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)
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
Time frame: Post-treatment (at delivery)
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).
Time frame: Post-treatment (at delivery)
Mean diastolic BP at 6 week postpartum (continuous)
Difference in diastolic BP between usual care and intervention group
Time frame: Post-treatment (6 weeks postpartum)
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).
Time frame: Post-treatment (at delivery)
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).
Time frame: Post-treatment (at delivery)
Perinatal loss (present/ absent)
Perinatal loss (present/ absent) will be abstracted from medical records
Time frame: Post-treatment (at delivery)
Neonatal intensive care unit admission (present/absent)
Neonatal intensive care unit admission (present/ absent) will be abstracted from medical records.
Time frame: Post-treatment (at delivery)
Primary cesarean delivery (present/absent)
Primary cesarean delivery (present/absent) will be abstracted from medical records.
Time frame: Post-treatment (at delivery)
Labor induction (present/ absent)
Labor induction (present/absent) will be abstracted from medical records.
Time frame: Post-treatment (at delivery)
Need for medication ( present/ absent)
Medication initiation will be abstracted from medical records
Time frame: Post-treatment (at delivery)
Pre-term birth ( present/ absent)
Gestational age at delivery will be abstracted from medical records
Time frame: Post-treatment (at delivery)
Hospital admissions ( present/ absent)
Hospital admissions will be abstracted from medical records
Time frame: Post-treatment (at delivery)
Mean systolic BP at 6 week postpartum
Difference in mean systolic blood pressure between usual care and intervention group
Time frame: Post-treatment (6 weeks postpartum)
Fasting glucose at 6 weeks postpartum ( only GDM)
Difference in fasting glucose between usual care and intervention group
Time frame: Post-treatment (6 weeks postpartum)
Postprandial glucose at 6 weeks postpartum ( only GDM)
Difference in postprandial glucose between usual care and intervention group
Time frame: Post-treatment (6 weeks postpartum)
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.
Time frame: at six weeks postpartum
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).
Time frame: at six weeks postpartum
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.
Time frame: at six weeks postpartum
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 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.
Access criteria: 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.
Started Jun 2026 (actual). Primary completion is estimated for Feb 2030, 43 months after the start.
Of 307 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's planned 43 months is above that.
Counting every sponsor, half of 310 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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