[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397191":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":127,"collaborators":24,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":24,"enrollmentInfo":139,"targetDuration":24,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early management GDM group","EXPERIMENTAL","defined as no intervention until GDM screening at 24-28 weeks' gestation. If there is a diagnosis of GDM at 24-28 according to the IADPSG criteria), intensive metabolic treatment until delivery",[13],"Other: early management strategy",{"label":15,"type":10,"description":16,"interventionNames":17},"Late management GDM group","early management of GDM defined as intensive metabolic treatment (diet, physical activity self-blood glucose monitoring according and\u002For insulin therapy according to the French guidelines). This intensive treatment will begin after the randomization until delivery.",[18],"Other: late management strategy",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"late management strategy","late management strategy of GDM defined as no intervention until GDM screening at 24-28 weeks. Between 24-28 weeks gestation, a 75-g OGTT will be done",[15],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"early management strategy","early management of GDM defined as intensive metabolic treatment. Intensive treatment involved the following multidisciplinary approach: lifestyle defined by diet and exercise intervention according to the French guidelines",[9],[30],{"name":31,"affiliation":5,"role":32},"Anne VAMBERGUE","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Anne VAMBERGUE, MD,PhD","CONTACT","0320445962","anne.vambergue@chru-lille.fr",[40,52,60,71,76,84,93,101,109,118],{"facility":41,"status":42,"city":43,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"CH ARRAS","RECRUITING","Arras","France","FR",{"type":47,"coordinates":48},"Point",[49,50],2.78186,50.29301,{"lat":50,"lon":49},{"facility":53,"status":42,"city":54,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":55,"geoPoint":59,"contacts":24},"Hopital Estaing - Chu63 - Clermont Ferrand","Clermont-Ferrand",{"type":47,"coordinates":56},[57,58],3.08682,45.77969,{"lat":58,"lon":57},{"facility":61,"status":42,"city":62,"state":24,"zip":63,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Hop Claude Huriez Chu Lille","Lille","59037",{"type":47,"coordinates":65},[66,67],3.05512,50.63391,{"lat":67,"lon":66},[70],{"name":24,"role":36,"phone":37,"phoneExt":24,"email":24},{"facility":72,"status":42,"city":62,"state":24,"zip":63,"country":44,"countryCode":45,"cosmosGeoPoint":73,"geoPoint":75,"contacts":24},"Hopital Saint Vincent - Saint Antoine - Lille",{"type":47,"coordinates":74},[66,67],{"lat":67,"lon":66},{"facility":77,"status":42,"city":78,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":24},"Chu Nimes Caremeau - Nimes 9","Nîmes",{"type":47,"coordinates":80},[81,82],4.35788,43.83665,{"lat":82,"lon":81},{"facility":85,"status":42,"city":86,"state":24,"zip":87,"country":44,"countryCode":45,"cosmosGeoPoint":88,"geoPoint":92,"contacts":24},"Hopital Haut-Leveque - Chu - Pessac","Pessac","33604",{"type":47,"coordinates":89},[90,91],-0.6324,44.80565,{"lat":91,"lon":90},{"facility":94,"status":42,"city":95,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":96,"geoPoint":100,"contacts":24},"Ch Rene Dubos - Pontoise","Pontoise",{"type":47,"coordinates":97},[98,99],2.1,49.05,{"lat":99,"lon":98},{"facility":102,"status":42,"city":103,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":104,"geoPoint":108,"contacts":24},"Chu Site Sud (Saint Pierre) - St Pierre","Saint-Pierre",{"type":47,"coordinates":105},[106,107],5.40682,43.29282,{"lat":107,"lon":106},{"facility":110,"status":42,"city":111,"state":24,"zip":112,"country":44,"countryCode":45,"cosmosGeoPoint":113,"geoPoint":117,"contacts":24},"Csapa \u002F Hus \u002F Hopital Civil - Strasbourg","Strasbourg","67091",{"type":47,"coordinates":114},[115,116],7.74553,48.58392,{"lat":116,"lon":115},{"facility":119,"status":42,"city":120,"state":24,"zip":121,"country":44,"countryCode":45,"cosmosGeoPoint":122,"geoPoint":126,"contacts":24},"Hopital de Rangueil Chu Toulouse","Toulouse","31300",{"type":47,"coordinates":123},[124,125],1.44367,43.60426,{"lat":125,"lon":124},{"type":128,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100397191","early-gestational-diabetes-mellitus-100397191",false,"NCT04451915","Early Gestational Diabetes Mellitus","Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial","LEMA_GDM","Inclusion Criteria:\n\n* Pregnant woman\n* Singleton pregnancy\n* Early GDM defined by a fasting plasma glucose between 5.1 mmol\u002Fl and 6.1 mmol\u002F with at least one risk factor (age ≥35 years and\u002For BMI ≥ 25 kg\u002Fm2 and\u002For familial history of diabetes and\u002For personal history of GDM and\u002For personal history of macrosomia).\n* First prenatal visit prior 20 weeks of gestation at the time of randomization.\n* Signed informed consent\n\nExclusion Criteria:\n\nDiabetic follow-up started at time of inclusion\n\n* Pre-existing diabetes in pregnancy\n* Renal impairment\n* Hepatic insufficiency\n* History of bariatric surgery\n* Long time corticosteroids treatment\n* Insufficient understanding\n* Language difficulties\n* Lack of social Insurance\n* Person in emergency situation\n* Person under the protection of justice (tutelage\u002F curatorship)\n* Persons deprived of their liberty","FEMALE","18 Years",{"count":140,"type":141},2010,"ESTIMATED","INTERVENTIONAL",[144],"NA","In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol\u002Fl should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.\n\nIn France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol\u002Fl, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo\u002FL is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol\u002Fl for the identification of GDM in early pregnancy is not justified by current evidence",[147],"Gestational Diabetes",[149,150,151,152,153],"Early gestational diabetes","pregnancy","fasting plasma glucose","diagnosis","prognosis","2026-05-28",{"date":156,"type":157},"2026-06-02","ACTUAL",{"date":159,"type":157},"2020-11-30",{"date":161,"type":141},"2027-06-30",{"name":5,"class":6},10]