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Study identifier: NCT04451915 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Early Gestational Diabetes Mellitus

Condition: Gestational Diabetes  ·  Sponsor: University Hospital, Lille

PhaseNA
Planned participants2010
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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/l 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. In 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/l, 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/L 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/l for the identification of GDM in early pregnancy is not justified by current evidence

This description comes directly from the study's public registry record.

Talk to the study team

Anne VAMBERGUE, MD,PhD  ·  0320445962  ·  anne.vambergue@chru-lille.fr

Always discuss trial participation with your own doctor first.

Locations (10)

CH ARRASArras, FranceRecruiting
Hopital Estaing - Chu63 - Clermont FerrandClermont-Ferrand, FranceRecruiting
Hop Claude Huriez Chu LilleLille, FranceRecruiting
Hopital Saint Vincent - Saint Antoine - LilleLille, FranceRecruiting
Chu Nimes Caremeau - Nimes 9Nîmes, FranceRecruiting
Hopital Haut-Leveque - Chu - PessacPessac, FranceRecruiting
Ch Rene Dubos - PontoisePontoise, FranceRecruiting
Chu Site Sud (Saint Pierre) - St PierreSaint-Pierre, FranceRecruiting
Csapa / Hus / Hopital Civil - StrasbourgStrasbourg, FranceRecruiting
Hopital de Rangueil Chu ToulouseToulouse, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04451915