Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD)
MOM-HD
1 other identifier
interventional
864
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2030
Study Completion
Last participant's last visit for all outcomes
December 31, 2030
December 3, 2025
November 1, 2025
3.5 years
November 17, 2025
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Mean systolic BP from recruitment to delivery (continuous)
Mean systolic BP levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and medical records (hospital measurements).
Post-treatment (at delivery)
Mean systolic BP averaged over 6 weeks postpartum
Mean systolic BP levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and medical records (hospital measurements). Values averaged from discharge to 6 weeks postpartum.
Post-treatment (6 weeks postpartum)
Rate of composite adverse perinatal outcome (categorical; either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery or labor induction)
Perinatal loss, neonatal intensive care unit admission, primary cesarean delivery or labor induction will be abstracted from medical records.
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)
BP levels or BG levels will be abstracted from the MOM-HD app (home measurements) and medical records (hospital measurements), and proportion of days with elevated readings (out of total number of days with valid measurements) will be calculated.
Post-treatment (at delivery)
Proportion of days with elevated blood pressure (BP) or blood glucose (BG) readings (above clinical target ranges) over 6 weeks postpartum (continuous)
BP levels or BG levels will be abstracted from the MOM-HD app (home measurements) and medical records (hospital measurements), and proportion of days with elevated readings (out of total number of days with valid measurements) will be calculated, spanning from discharge to 6 weeks postpartum
Post-treatment (at delivery)
Secondary Outcomes (11)
Mean diastolic BP from recruitment to delivery (continuous)
Post-treatment (at delivery)
Mean diastolic BP over the 6 weeks postpartum (continuous)
Post-treatment (6 weeks postpartum)
Mean fasting BG levels from recruitment to delivery (continuous; only among women with GDM)
Post-treatment (at delivery)
Mean postprandial BG levels from recruitment to delivery (continuous; only among women with GDM)
Post-treatment (at delivery)
Perinatal loss (present/ absent)
Post-treatment (at delivery)
- +6 more secondary outcomes
Other Outcomes (3)
App usage (Intervention group only)
at six weeks postpartum
App compliance ( Intervention group only)
at six weeks postpartum
Usability ( Intervention group only)
at six weeks postpartum
Study Arms (2)
MOM-HD Intervention Group
EXPERIMENTALIn 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.
Standard Care Group
ACTIVE COMPARATORIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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) or Gestational hypertension (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
You may not qualify if:
- Multifetal pregnancies
- Apparent communication difficulties (e.g., hearing, speech, or cognitive impairments), as judged by research assistants
- Unable to understand the Nepali language
- Requires hospital admission due to severe illness
- Declines to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- Dhulikhel Hospitalcollaborator
- Institute for Implementation Science and Healthcollaborator
Related Publications (3)
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PMID: 25103301BACKGROUNDMurray SR, Reynolds RM. Short- and long-term outcomes of gestational diabetes and its treatment on fetal development. Prenat Diagn. 2020 Aug;40(9):1085-1091. doi: 10.1002/pd.5768. Epub 2020 Jul 1.
PMID: 32946125BACKGROUNDGlasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
PMID: 10474547BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shristi Rawal, PhD
Rutgers School of Health Professions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The allocation sequence will be concealed from the research nurse and participants using sequentially numbered opaque sealed envelopes.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 24, 2025
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 28, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.