[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469118":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":24,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":24,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Massachusetts, Worcester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced First Trimester GDM Screening","EXPERIMENTAL","Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.",[13],"Diagnostic Test: Enhanced First Trimester GDM Screening",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care GDM Screening","ACTIVE_COMPARATOR","Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.",[19],"Diagnostic Test: Routine Gestational Diabetes Screening",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST",[9],null,{"type":22,"name":26,"description":17,"armGroupLabels":27,"otherNames":28},"Routine Gestational Diabetes Screening",[15],[29],"Third Trimester Screening",[31],{"name":32,"affiliation":5,"role":33},"Gianna Wilkie, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Gianna L Wilkie, MD","CONTACT","77743642523","Gianna.Wilkie@umassmemorial.org",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Massachusetts Memorial Medical Center","RECRUITING","Worcester","Massachusetts","01605","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.80229,42.26259,{"lat":53,"lon":52},[56],{"name":36,"role":37,"phone":57,"phoneExt":24,"email":39},"508-334-4067",{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Gianna Wilkie","Principal Investigator",[62],{"name":63,"class":64},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100469118","early-detection-of-gestational-diabetes-mellitus-in-pregnancy-100469118",false,"NCT05388643","Early Detection of Gestational Diabetes Mellitus in Pregnancy","Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial","Inclusion Criteria:\n\n* 1\\) age greater than or equal to 18 years old,\n* 2\\) singleton gestation less than or equal to 12 weeks at initial obstetric visit,\n* 3\\) receiving prenatal care at UMMHC and plans to deliver at UMMHC,\n* 4\\) able and willing to provide informed consent,\n* 5\\) English or Spanish speaking, and\n* 6\\) are at high risk for developing GDM by ACOG clinical risk factor guidelines.\n\nExclusion Criteria:\n\n* 1\\) known diagnosis of pre-existing pregestational diabetes,\n* 2\\) plan to receive prenatal care or deliver outside of UMMHC,\n* 3\\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or\n* 4\\) systemic steroid use.","FEMALE","18 Years",{"count":75,"type":76},80,"ESTIMATED","INTERVENTIONAL",[79],"NA","The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).",[82,83],"Gestational Diabetes Mellitus in Pregnancy","Pregnancy, High Risk",[85,86,87,88,89],"Pregnancy","Gestational Diabetes","Screening","Maternal Outcomes","Neonatal Outcomes","2026-03-31",{"date":92,"type":93},"2026-04-06","ACTUAL",{"date":95,"type":93},"2025-07-01",{"date":97,"type":76},"2026-12-01",{"name":5,"class":6},1]