[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611692":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":47,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":23,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":26,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":26},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: MOM-HD",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Standard Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"affiliation":34,"role":35},"Shristi Rawal, PhD","Rutgers School of Health Professions","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+18606908495","shristi.rawal@rutgers.edu",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Archana Shrestha, PhD","+9779801002245","archana@kusms.edu.np",{"type":35,"investigatorFullName":33,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor",[48,50],{"name":49,"class":6},"Dhulikhel Hospital",{"name":51,"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\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":62,"type":63},864,"ESTIMATED","INTERVENTIONAL",[66],"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.",[69,70],"Gestational Diabetes","Hypertensive Disorder of Pregnancy",[72,73,74,75,76,77,78],"pregnancy","telemonitoring","mHealth","GDM","HDP","Nepal","implementation","NOT_YET_RECRUITING","2026-06-03",{"date":82,"type":83},"2026-06-05","ACTUAL",{"date":85,"type":63},"2026-09-01",{"date":87,"type":63},"2030-12-31",{"name":5,"class":6}]