Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD) (MOM-HD)

July 29, 2026 updated by: Shristi Rawal, PhD, Rutgers, The State University of New Jersey

Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD): a Type II Hybrid Implementation-Effectiveness Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
864

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Nepal
      • Biratnagar, Nepal
        • Recruiting
        • Nobel Medical College & Teaching Hospital
        • Contact:
          • Isha Puuri
      • Dhulikhel, Nepal
        • Recruiting
        • Dhulikhel Hospital
        • Contact:
          • Archana Shrestha
      • Kathmandu, Nepal
        • Recruiting
        • Paropakar Maternity and Women's Hospital
        • Contact:
          • Yunika Acharya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Able to read and write

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MOM-HD Intervention Group
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
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.
Active Comparator: Standard Care Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean systolic BP from recruitment to delivery (continuous)
Time Frame: Post-treatment (at delivery)
Difference in mean systolic blood pressure between usual care and intervention group
Post-treatment (at delivery)
Rate of composite adverse perinatal outcome (categorical; either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery, preterm birth )
Time Frame: Post-treatment (at delivery)
Perinatal loss, neonatal intensive care unit admission, primary cesarean delivery, preterm birth 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)
Time Frame: Post-treatment (at delivery)
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
Post-treatment (at delivery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perinatal loss (present/ absent)
Time Frame: Post-treatment (at delivery)
Perinatal loss (present/ absent) will be abstracted from medical records
Post-treatment (at delivery)
Neonatal intensive care unit admission (present/absent)
Time Frame: Post-treatment (at delivery)
Neonatal intensive care unit admission (present/ absent) will be abstracted from medical records.
Post-treatment (at delivery)
Primary cesarean delivery (present/absent)
Time Frame: Post-treatment (at delivery)
Primary cesarean delivery (present/absent) will be abstracted from medical records.
Post-treatment (at delivery)
Need for medication ( present/ absent)
Time Frame: Post-treatment (at delivery)
Medication initiation will be abstracted from medical records
Post-treatment (at delivery)
Pre-term birth ( present/ absent)
Time Frame: Post-treatment (at delivery)
Gestational age at delivery will be abstracted from medical records
Post-treatment (at delivery)
Hospital admissions ( present/ absent)
Time Frame: Post-treatment (at delivery)
Hospital admissions will be abstracted from medical records
Post-treatment (at delivery)
Mean diastolic BP from recruitment to delivery (continuous)
Time Frame: Post-treatment (at delivery)
Mean diastolic BP levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and/or medical records (hospital measurements).
Post-treatment (at delivery)
Mean diastolic BP at 6 week postpartum (continuous)
Time Frame: Post-treatment (6 weeks postpartum)
Difference in diastolic BP between usual care and intervention group
Post-treatment (6 weeks postpartum)
Mean fasting BG levels from recruitment to delivery (continuous; only among women with GDM)
Time Frame: Post-treatment (at delivery)
Mean BG levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and/or medical records (hospital measurements).
Post-treatment (at delivery)
Mean postprandial BG levels from recruitment to delivery (continuous; only among women with GDM)
Time Frame: Post-treatment (at delivery)
Mean BG levels will be calculated based on data abstracted from the MOM-HD app (home measurements) and/or medical records (hospital measurements).
Post-treatment (at delivery)
Labor induction (present/ absent)
Time Frame: Post-treatment (at delivery)
Labor induction (present/absent) will be abstracted from medical records.
Post-treatment (at delivery)
Mean systolic BP at 6 week postpartum
Time Frame: Post-treatment (6 weeks postpartum)
Difference in mean systolic blood pressure between usual care and intervention group
Post-treatment (6 weeks postpartum)
Fasting glucose at 6 weeks postpartum ( only GDM)
Time Frame: Post-treatment (6 weeks postpartum)
Difference in fasting glucose between usual care and intervention group
Post-treatment (6 weeks postpartum)
Postprandial glucose at 6 weeks postpartum ( only GDM)
Time Frame: Post-treatment (6 weeks postpartum)
Difference in postprandial glucose between usual care and intervention group
Post-treatment (6 weeks postpartum)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
App usage (Intervention group only)
Time Frame: at six weeks postpartum
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.
at six weeks postpartum
App compliance ( Intervention group only)
Time Frame: at six weeks postpartum
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).
at six weeks postpartum
Usability ( Intervention group only)
Time Frame: at six weeks postpartum
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.
at six weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dhulikhel Hospital
Institute for Implementation Science and Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shristi Rawal, PhD, Rutgers School of Health Professions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2025001611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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