[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611692":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":81,"studyPopulation":77,"armGroups":82,"interventions":95,"overallOfficials":105,"centralContacts":110,"locations":119,"responsibleParty":157,"collaborators":159,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":98,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":77,"enrollmentInfo":172,"targetDuration":77,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":122,"whyStopped":77,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":61},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Mean systolic BP from recruitment to delivery (continuous)","Difference in mean systolic blood pressure between usual care and intervention group","Post-treatment (at delivery)",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":18,"timeFrame":12},"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",[20,23,27,30,32,35,38,41,44,47,50,53,55,58],{"measure":21,"description":22,"timeFrame":12},"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\u002For medical records (hospital measurements).",{"measure":24,"description":25,"timeFrame":26},"Mean diastolic BP at 6 week postpartum (continuous)","Difference in diastolic BP between usual care and intervention group","Post-treatment (6 weeks postpartum)",{"measure":28,"description":29,"timeFrame":12},"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\u002For medical records (hospital measurements).",{"measure":31,"description":29,"timeFrame":12},"Mean postprandial BG levels from recruitment to delivery (continuous; only among women with GDM)",{"measure":33,"description":34,"timeFrame":12},"Perinatal loss (present\u002F absent)","Perinatal loss (present\u002F absent) will be abstracted from medical records",{"measure":36,"description":37,"timeFrame":12},"Neonatal intensive care unit admission (present\u002Fabsent)","Neonatal intensive care unit admission (present\u002F absent) will be abstracted from medical records.",{"measure":39,"description":40,"timeFrame":12},"Primary cesarean delivery (present\u002Fabsent)","Primary cesarean delivery (present\u002Fabsent) will be abstracted from medical records.",{"measure":42,"description":43,"timeFrame":12},"Labor induction (present\u002F absent)","Labor induction (present\u002Fabsent) will be abstracted from medical records.",{"measure":45,"description":46,"timeFrame":12},"Need for medication ( present\u002F absent)","Medication initiation will be abstracted from medical records",{"measure":48,"description":49,"timeFrame":12},"Pre-term birth ( present\u002F absent)","Gestational age at delivery will be abstracted from medical records",{"measure":51,"description":52,"timeFrame":12},"Hospital admissions ( present\u002F absent)","Hospital admissions will be abstracted from medical records",{"measure":54,"description":11,"timeFrame":26},"Mean systolic BP at 6 week postpartum",{"measure":56,"description":57,"timeFrame":26},"Fasting glucose at 6 weeks postpartum ( only GDM)","Difference in fasting glucose between usual care and intervention group",{"measure":59,"description":60,"timeFrame":26},"Postprandial glucose at 6 weeks postpartum ( only GDM)","Difference in postprandial glucose between usual care and intervention group",[62,66,69],{"measure":63,"description":64,"timeFrame":65},"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\u002FBG), time of day the app\u002Ffeature was used, and time spent in each feature.","at six weeks postpartum",{"measure":67,"description":68,"timeFrame":65},"App compliance ( Intervention group only)","Self-monitoring frequency data, such as the number of BP\u002FBG 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).",{"measure":70,"description":71,"timeFrame":65},"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.",{"allocation":73,"interventionModel":74,"interventionModelDescription":75,"primaryPurpose":76,"observationalModel":77,"timePerspective":77,"maskingInfo":78},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",null,{"masking":79,"maskingDescription":80,"whoMasked":77},"NONE","The allocation sequence will be concealed from the research nurse and participants using sequentially numbered opaque sealed envelopes.","This is a Mobile-based Obstetric Monitoring for Hypertension and\u002For Diabetes (MOM-HD)2 program, which includes a patient-facing mobile app for uploading BP\u002FBG data, a provider-facing web portal for viewing patient data, and biweekly tele-visits with a study nurse.\n\nThis 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\u002For BG monitoring; (b) Provide financial assistance for at-home BP and\u002For BG monitoring; (c) Technical assistance, audit, and feedback to the providers; and (d) Institutionalizing and sustaining the program through advisory boards at each hospital.\n\nStudy Objective and Aims\n\nPrimary Goal:\n\nTo 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.\n\nSpecific aims:\n\n* Aim 1: Assess the effectiveness of MOM-HD + standard care compared to standard care alone via a multi-center randomized controlled trial.\n* Aim 2: Assess implementation outcomes of the MOM-HD using the RE-AIM framework at the patient, provider, and health system levels.\n* Aim 3: Conduct a comprehensive costing analysis and economic evaluation of the MOM-HD.\n\nStudy Design\n\nThis 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.\n\nThe MOM-HD telemonitoring program will consist of patient education\u002F training, provision of a BP monitor and\u002For glucometer and strips, a mobile app where BP\u002FBG 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\u002For GDM in the intervention group will be enrolled in the MOM-HD program from enrollment to 6 weeks postpartum.\n\nOverall, 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.\n\nStudy Duration\n\nThe study is expected to last up to 5 years. Participants will be followed from 24-30 weeks' gestation until 6 weeks postpartum.\n\nSample Size\n\nA total of 864 participants (432 with HDP and 432 with GDM).\n\nRandomization\n\nParticipants 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).\n\nParticipants 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.\n\nPregnant 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.\n\nStudy Population: See section Eligibility\n\nMeasurements\n\n* Primary and Secondary Outcomes: See section Outcome Measures\n* 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).\n\nIntervention: See section Arms and Interventions\n\nResearch Method: Mixed-method and Randomized Clinical Trial",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"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\u002For glucometer, and a mobile app for uploading daily BP\u002Fblood 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\u002FBG 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\u002FGYNs 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.",[88],"Behavioral: MOM-HD",{"label":90,"type":91,"description":92,"interventionNames":93},"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\u002FBG monitoring, with results recorded in paper booklets assigned to each patient. Additionally, women are encouraged to regularly monitor their BP and\u002For 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\u002FGYN physicians monitor BP\u002FBG levels and adjust medications accordingly. Follow-up BP\u002FBG testing is conducted six weeks postpartum.",[94],"Other: Standard Care",[96,101],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":77},"BEHAVIORAL","MOM-HD","Participants will receive education and training on proper BP and\u002For BG monitoring and will be provided a BP monitor and\u002For 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.",[84],{"type":6,"name":102,"description":103,"armGroupLabels":104,"otherNames":77},"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\u002FBG monitoring with paper record booklets, dietary and physical activity counseling, and OB\u002FGYN follow-up. GDM patients will consult with a dietitian and physical therapist. Postpartum follow-up includes BP\u002FBG testing at 6 weeks.",[90],[106],{"name":107,"affiliation":108,"role":109},"Shristi Rawal, PhD","Rutgers School of Health Professions","PRINCIPAL_INVESTIGATOR",[111,115],{"name":107,"role":112,"phone":113,"phoneExt":77,"email":114},"CONTACT","+18606908495","shristi.rawal@rutgers.edu",{"name":116,"role":112,"phone":117,"phoneExt":77,"email":118},"Archana Shrestha, PhD","+9779801002245","archana@kusms.edu.np",[120,135,146],{"facility":121,"status":122,"city":123,"state":77,"zip":77,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"Nobel Medical College & Teaching Hospital","RECRUITING","Biratnagar","Nepal","NP",{"type":127,"coordinates":128},"Point",[129,130],87.27007,26.45505,{"lat":130,"lon":129},[133],{"name":134,"role":112,"phone":77,"phoneExt":77,"email":77},"Isha Puuri",{"facility":136,"status":122,"city":137,"state":77,"zip":77,"country":124,"countryCode":125,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Dhulikhel Hospital","Dhulikhel",{"type":127,"coordinates":139},[140,141],85.54281,27.6221,{"lat":141,"lon":140},[144],{"name":145,"role":112,"phone":77,"phoneExt":77,"email":77},"Archana Shrestha",{"facility":147,"status":122,"city":148,"state":77,"zip":77,"country":124,"countryCode":125,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Paropakar Maternity and Women's Hospital","Kathmandu",{"type":127,"coordinates":150},[151,152],85.3206,27.70169,{"lat":152,"lon":151},[155],{"name":156,"role":112,"phone":77,"phoneExt":77,"email":77},"Yunika Acharya",{"type":109,"investigatorFullName":107,"investigatorTitle":158,"investigatorAffiliation":5,"oldNameTitle":77,"oldOrganization":77},"Associate Professor",[160,161],{"name":136,"class":6},{"name":162,"class":6},"Institute for Implementation Science and Health","100611692","mobile-based-obstetric-monitoring-for-pregnancies-complicated-by-hypertension-andor-diabetes-mom-hd-100611692",false,"NCT07243886","Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and\u002For Diabetes (MOM-HD)","Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and\u002For Diabetes (MOM-HD): a Type II Hybrid Implementation-Effectiveness Trial","Inclusion Criteria:\n\n* Pregnant women receiving antenatal care at RCT site\n* Diagnosed with one of the following:\n\n  * Chronic hypertension (sustained systolic BP ≥140 mm Hg and\u002For diastolic BP ≥90 mm Hg, or on antihypertensive treatment before 20 weeks of gestation)\n  * Gestational hypertension or preeclampsia without severe features (sustained systolic BP ≥140 mm Hg and\u002For diastolic BP ≥90 mm Hg after 20 weeks of gestation)\n  * Gestational diabetes\n* Age 18 years or older\n* Access to a smartphone\n* Gestational age ≤ 34 weeks at enrollment\n* Able to read and write\n\nExclusion Criteria:\n\n* Multifetal pregnancies\n* Apparent communication difficulties (e.g., hearing, speech, or cognitive impairments), as judged by research assistants\n* Unable to understand the Nepali language\n* 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)\n* Declines to provide informed consent","FEMALE","18 Years",{"count":173,"type":174},864,"ESTIMATED","INTERVENTIONAL",[177],"NA","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.\n\nHere 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\u002For 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.",[180,181],"Gestational Diabetes","Hypertensive Disorder of Pregnancy",[183,184,185,186,187,124,188],"pregnancy","telemonitoring","mHealth","GDM","HDP","implementation","2026-07-29",{"date":191,"type":192},"2026-07-31","ACTUAL",{"date":194,"type":192},"2026-06-30",{"date":196,"type":174},"2030-12-31",{"name":5,"class":6},3]