Gestational DiabetesMOM-HDNCT07243886
Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD)
A study testing MOM-HD in people with Gestational Diabetes and Hypertensive Disorder of Pregnancy, run by Rutgers, The State University of New Jersey at 3 sites in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Hypertensive Disorder of Pregnancy
- What is being tested?
- MOM-HD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 3 sitesNepal
- Study dates
- 30 Jun 2026to 31 Dec 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Access to a smartphone
- Gestational age ≤ 34 weeks at enrollment
- Able to read and write
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal3 sites, 3 recruiting
- Recruiting
Nobel Medical College & Teaching Hospital
Biratnagar
Isha Puuri
- Recruiting
Dhulikhel Hospital
Dhulikhel
Archana Shrestha
- Recruiting
Paropakar Maternity and Women's Hospital
Kathmandu
Yunika Acharya
About this study
Official title: 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.
Read the 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
- Being tested
- MOM-HD, Standard Care
- Keywords
- pregnancy, telemonitoring, mHealth, GDM, HDP, Nepal, implementation
- Medical subject headings
- Diabetes, Gestational, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOM-HDBehavioural
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.
Standard CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MOM-HD Intervention Group | Experimental | 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. Receives: Behavioral: MOM-HD |
| Standard Care Group | Active comparator | 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systolic BP from recruitment to delivery (continuous)
Difference in mean systolic blood pressure between usual care and intervention group
Measured: 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.
Measured: 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
Measured: Post-treatment (at delivery)
Secondary outcomes (14)
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).
Measured: Post-treatment (at delivery)
Mean diastolic BP at 6 week postpartum (continuous)
Difference in diastolic BP between usual care and intervention group
Measured: 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).
Measured: 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).
Measured: Post-treatment (at delivery)
Perinatal loss (present/ absent)
Perinatal loss (present/ absent) will be abstracted from medical records
Measured: Post-treatment (at delivery)
Neonatal intensive care unit admission (present/absent)
Neonatal intensive care unit admission (present/ absent) will be abstracted from medical records.
Measured: Post-treatment (at delivery)
Primary cesarean delivery (present/absent)
Primary cesarean delivery (present/absent) will be abstracted from medical records.
Measured: Post-treatment (at delivery)
Labor induction (present/ absent)
Labor induction (present/absent) will be abstracted from medical records.
Measured: Post-treatment (at delivery)
Need for medication ( present/ absent)
Medication initiation will be abstracted from medical records
Measured: Post-treatment (at delivery)
Pre-term birth ( present/ absent)
Gestational age at delivery will be abstracted from medical records
Measured: Post-treatment (at delivery)
Hospital admissions ( present/ absent)
Hospital admissions will be abstracted from medical records
Measured: Post-treatment (at delivery)
Mean systolic BP at 6 week postpartum
Difference in mean systolic blood pressure between usual care and intervention group
Measured: Post-treatment (6 weeks postpartum)
Fasting glucose at 6 weeks postpartum ( only GDM)
Difference in fasting glucose between usual care and intervention group
Measured: Post-treatment (6 weeks postpartum)
Postprandial glucose at 6 weeks postpartum ( only GDM)
Difference in postprandial glucose between usual care and intervention group
Measured: Post-treatment (6 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start30 Jun 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In total, 864 participants (432 patients with HDP and 432 patients with GDM will be randomly assigned in a 1:1 fashion to one of two treatment conditions: either (i) MOM-HD program+ standard care or (ii) standard care only from enrolment into pregnancy till six weeks postpartum. Random permuted blocks of sizes 4 or 6 will be employed using statistical software to prevent treatment imbalance and ensure that participants are allocated to each group equally.
- Masking
- None (open label)
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Dhulikhel Hospital, Institute for Implementation Science and Health
- Responsible party
- Principal investigator, Shristi Rawal, PhD, Rutgers, The State University of New Jersey
- Investigators
- Shristi Rawal, PhD, Principal investigator, Rutgers School of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243886
- Sponsor's protocol ID
- Pro2025001611
- Acronym
- MOM-HD
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 25103301Murray 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.
PubMed 32946125Glasgow 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.
PubMed 10474547