[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570191":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":50,"collaborators":52,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"National University Hospital, Singapore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early OGTT Results Revealed","EXPERIMENTAL","The results of the early OGTT conducted before 16 weeks' gestation will be revealed to the participants. If the results indicate gestational diabetes mellitus (GDM) by the WHO 2013 criteria, immediate follow-up actions, including appropriate treatments, will be taken. Those with a normal result will undertake the universally offered routine OGTT at 24-28 weeks' gestation.",[13],"Diagnostic Test: Early OGTT Results Revealed",{"label":15,"type":16,"description":17,"interventionNames":18},"Early OGTT Results Concealed","NO_INTERVENTION","Participants in this arm will undergo an early oral glucose tolerance test (OGTT) before 16 weeks' gestation, however, the results will be concealed from the participants and study investigators, and results will not be acted upon (unless they are suggestive of pre-existing type 2 diabetes mellitus as reviewed by an independent clinician, in which case appropriate follow-up will be arranged). All participants (except those with results suggestive of type 2 diabetes) will undertake the routine OGTT at 24-28 weeks' gestation, as per standard care.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DIAGNOSTIC_TEST","Early pregnancy screening with a three-time point (fasting, 1h, 2h) 75g oral glucose tolerance test before 16 weeks' gestation with plasma glucose results revealed to the patient and clinician for appropriate management of any diabetes (gestational and type 2, if diagnosed) from early pregnancy onwards.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Gladys Woon, BSc","CONTACT","+65 6516 4134","gladys_woon@nuhs.edu.sg",[31],{"facility":32,"status":18,"city":33,"state":18,"zip":34,"country":33,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"National University Hospital","Singapore","119228","SG",{"type":37,"coordinates":38},"Point",[39,40],103.85007,1.28967,{"lat":40,"lon":39},[43,44,47],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"name":45,"role":46,"phone":18,"phoneExt":18,"email":18},"Shiao-Yng Chan, MBBChir (UK), FRCOG (UK), PhD","PRINCIPAL_INVESTIGATOR",{"name":48,"role":49,"phone":18,"phoneExt":18,"email":18},"Karen Lim, MBBS, MRCOG, MMED, MSc","SUB_INVESTIGATOR",{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[53,55],{"name":54,"class":6},"National University of Singapore",{"name":56,"class":6},"Agency for Science, Technology and Research","100570191","early-screening-for-gestational-diabetes-mellitus-in-a-low-risk-population-100570191",false,"NCT06704035","Early Screening for Gestational Diabetes Mellitus in a Low Risk Population","EaGeR","Inclusion Criteria:\n\n1. Pregnant women aged 21-39 years at recruitment\n2. Singleton pregnancy\n3. Less than 16 weeks pregnant at recruitment\n4. Intend to receive antenatal care and give birth at the National University Hospital\n\nExclusion Criteria:\n\n1. Known pre-existing type 1 or type 2 diabetes mellitus at recruitment\n2. Classified as high-risk for GDM at pregnancy booking using the traditional checklist:\n\n   2.1) Age ≥40 years 2.2) Overweight\u002Fobese, i.e., body mass index (BMI) ≥25.0 kg\u002Fm2 2.3) First degree relative with diabetes mellitus 2.4) Previously delivered a baby ≥4 kg 2.5) Previously diagnosed with GDM 2.6) Impaired glucose tolerance (IGT) or impaired fasting glycaemia (IFG) on previous testing 2.7) Polycystic ovarian syndrome (PCOS) 2.8) Poor obstetric history (e.g. recurrent pregnancy loss, previous intrauterine death, congenital malformations) 2.9) History of chronic hypertension, hyperlipidaemia or cardiovascular disease 2.10) Glycosuria ≥ 2+ on urine dipstick\n3. Taking systemic steroid medication or metformin\n4. Participation in another intervention trial",true,"FEMALE","21 Years","39 Years",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"NA","This new feasibility pilot study aims to refine the design and protocols for a larger trial that will investigate the potential benefits of early oral glucose tolerance test (OGTT) screening in a population traditionally defined as low-risk for development of gestational diabetes. The study will evaluate its potential effectiveness in reducing the risks of neonatal morbidity\u002Fmortality and obstetric complications. Additionally, a machine learning algorithm to predict gestational diabetes mellitus (GDM) risk based on routinely obtained clinical information at pregnancy booking, and minimally invasive methods, such as continuous glucose monitoring (CGM) and gingival crevicular fluid (GCF) sampling, are being explored to predict the risk of hyperglycaemia. This study aims to investigate the utility of early pregnancy screening to enable timely detection and management of early gestational diabetes development in a low-risk population, ultimately promoting better health outcomes for mothers and their babies.",[76,77],"Gestational Diabetes Mellitus (GDM)","Glucose Intolerance During Pregnancy",[79,80,81,82,83,84,85,86,87,88],"Early screening","Gestational diabetes","Oral glucose tolerance test (OGTT)","Neonatal complications","Pregnancy complications","Machine learning algorithm","Continuous glucose monitoring (CGM)","Gingival crevicular fluid (GCF)","IADPSG criteria","WHO 2013 gestational diabetes criteria","NOT_YET_RECRUITING","2024-11-21",{"date":92,"type":93},"2024-11-25","ACTUAL",{"date":95,"type":70},"2024-12-01",{"date":97,"type":70},"2026-11-30",{"name":5,"class":6},1]