[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648014":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":68,"studyPopulation":68,"armGroups":72,"interventions":83,"overallOfficials":88,"centralContacts":95,"locations":104,"responsibleParty":122,"collaborators":68,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":68,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":132,"minAge":133,"maxAge":68,"enrollmentInfo":134,"targetDuration":68,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":148,"whyStopped":68,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Maternal Near Miss","life-threatening complication during pregnancy, childbirth, or within 42 days postpartum, but survives with appropriate medical intervention (We will use WHO criteria)","up to 60 days postpartum",[14,18,22,26,30,33,37,41,44,48,51],{"measure":15,"description":16,"timeFrame":17},"Neonatal death","Number of neonatal deaths, defined as death of a liveborn infant within the first 28 days of life","Up to 28 days after birth",{"measure":19,"description":20,"timeFrame":21},"Low Apgar Score at 5 Minutes","Number of infants with an Apgar score less than 7 at 5 minutes after birth","At 5 minutes after birth",{"measure":23,"description":24,"timeFrame":25},"Neonatal Intensive Care Unit Admission","Number of infants admitted to a neonatal intensive care unit","Up to 30 days after birth",{"measure":27,"description":28,"timeFrame":29},"Need for Mechanical Ventilation","Number of infants requiring mechanical ventilation","up to 30 days after birth",{"measure":31,"description":32,"timeFrame":25},"Neonatal Respiratory Distress Syndrome","Number of infants diagnosed with respiratory distress syndrome",{"measure":34,"description":35,"timeFrame":36},"Neonatal Hypoglycemia","Number of infants with hypoglycemia, defined as less than 45 mg\u002Fdl","Up to 48 hours after birth",{"measure":38,"description":39,"timeFrame":40},"Low Birth Weight","Number of infants with birth weight less than 2500 grams","At birth",{"measure":42,"description":43,"timeFrame":29},"Composite Adverse Neonatal Outcome","Number of infants with at least one of the following: neonatal death, Apgar score less than 7 at 5 minutes, NICU admission, need for mechanical ventilation, respiratory distress syndrome, hypoglycemia",{"measure":45,"description":46,"timeFrame":47},"Antenatal Risk Screening Rate","Proportion of pregnant women enrolled in the study who undergo antenatal risk screening using the Antenatal Risk-Score Checklist","Up to 24 months",{"measure":49,"description":50,"timeFrame":47},"Referral Rate","Percentage of pregnant women referred to higher levels of care based on risks identified through antenatal risk screening",{"measure":52,"description":53,"timeFrame":47},"Telehealth Consultation Utilization Rate","Proportion of pregnant women in the High Risk Pregnancy Bundle Intervention Arm who utilize at least 80% of their recommended telehealth consultations",[55,59,62],{"measure":56,"description":57,"timeFrame":58},"Acceptability of Intervention Measure (AIM) Score","We will assess the acceptability of each intervention component (risk-screening scoring system, teleconsultation, weekly patient navigator calls, and provider training) using the mean total score and standard deviation (SD) of the Acceptability of Intervention Measure (AIM), administered at both the patient and provider level.","up to 24 months",{"measure":60,"description":61,"timeFrame":47},"Intervention Appropriateness Measure (IAM) Score","We will assess the appropriateness of each intervention component (risk-screening scoring system, teleconsultation, weekly patient navigator calls, and provider training) using the mean total score and standard deviation (SD) of the Intervention Appropriateness Measure (IAM), administered at both the patient and provider level.",{"measure":63,"description":64,"timeFrame":47},"Feasibility of Intervention Measure (FIM) Score","We will assess the feasibility of each intervention component (risk-screening scoring system, teleconsultation, weekly patient navigator calls, and provider training) using the mean total score and standard deviation (SD) of the Feasibility of Intervention Measure (FIM), administered at both the patient and provider level.",{"allocation":66,"interventionModel":67,"interventionModelDescription":68,"primaryPurpose":69,"observationalModel":68,"timePerspective":68,"maskingInfo":70},"RANDOMIZED","PARALLEL",null,"HEALTH_SERVICES_RESEARCH",{"masking":71,"maskingDescription":68,"whoMasked":68},"NONE",[73,77],{"label":74,"type":75,"description":76,"interventionNames":68},"Standard of Care","NO_INTERVENTION","Usual prenatal care, including on-site consultation and visits from health facility staff",{"label":78,"type":79,"description":80,"interventionNames":81},"High Risk Pregnancy (HRP) Bundle Intervention Arm","ACTIVE_COMPARATOR","The intervention arm would include 1. identification of high-risk pregnancy 2. Teleconsultation with expert consultant 3. weekly call with patient navigator 4. training of health care provider for HRP care, and 5. visits in the weekly prenatal telehealth clinic",[82],"Other: High Risk Pregnancy Bundle",[84],{"type":6,"name":85,"description":86,"armGroupLabels":87,"otherNames":68},"High Risk Pregnancy Bundle","The intervention would include 1. identification of high-risk pregnancy 2. Teleconsultation with expert consultant 3. weekly call with patient navigator 4. training of health care provider for HRP care, and 5. visits in the weekly prenatal telehealth clinic",[78],[89,92],{"name":90,"affiliation":5,"role":91},"Anju Ranjit, MD MPH","PRINCIPAL_INVESTIGATOR",{"name":93,"affiliation":94,"role":91},"Archana Shrestha","Kathmandu University School of Medicine\u002FDhulikhel Hospital",[96,100],{"name":90,"role":97,"phone":98,"phoneExt":68,"email":99},"CONTACT","4153533400","anju.ranjit@ucsf.edu",{"name":101,"role":97,"phone":102,"phoneExt":68,"email":103},"Archana Shrestha, PhD","+9779801002245","archana@kusms.edu.np",[105],{"facility":106,"status":68,"city":107,"state":108,"zip":68,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Melamchi Primary Health Care Center","Melamchi","Bagmati","Nepal","NP",{"type":112,"coordinates":113},"Point",[114,115],85.57878,27.83028,{"lat":115,"lon":114},[118],{"name":119,"role":97,"phone":120,"phoneExt":68,"email":121},"Umang Raut (Medical Superintendent)","+977 9860923221","melamchiphc@gmail.com",{"type":123,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR","100648014","antenatal-high-risk-pregnancy-intervention-bundle-in-rural-nepal-100648014",false,"NCT07717619","Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal","Implementing and Evaluating an Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal","Inclusion Criteria:\n\n* all pregnant women above who are receiving antenatal care at Melamchi Primary Health Care Center\n\nExclusion Criteria:\n\n* life-threatening maternal or fetal conditions requiring immediate tertiary-level care\n* unable to provide informed consent due to cognitive or language barriers\n* do not have access to a mobile phone for telehealth consultations.",true,"FEMALE","0 Years",{"count":135,"type":136},100,"ESTIMATED","INTERVENTIONAL",[139],"NA","The proposed study will assess and implement a comprehensive antenatal HRP screening and telehealth follow-up program in rural Nepal. The main questions it aims to answer are:\n\n1. To estimate the burden of HRPs using the existing Antenatal Risk-Score Checklist in rural Nepal\n2. Assess acceptability, feasibility, preliminary effectiveness, and implementation outcomes of the HRP bundle at the primary healthcare in Nepal",[142],"High Risk Pregnancy",[144,145,146,147],"high risk pregnancy","low and middle income countries","teleheatlh","pregnancy checklist","NOT_YET_RECRUITING","2026-07-15",{"date":151,"type":152},"2026-07-21","ACTUAL",{"date":154,"type":136},"2026-08-01",{"date":156,"type":136},"2028-07-31",{"name":5,"class":6},1]