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Early Gestational Diabetes Mellitus

Early Gestational Diabetes Mellitus

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

Eligibility

Inclusion Criteria:

  • Pregnant woman
  • Singleton pregnancy
  • Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of GDM and/or personal history of macrosomia).
  • First prenatal visit prior 20 weeks of gestation at the time of randomization.
  • Signed informed consent

Exclusion Criteria:

Diabetic follow-up started at time of inclusion

  • Pre-existing diabetes in pregnancy
  • Renal impairment
  • Hepatic insufficiency
  • History of bariatric surgery
  • Long time corticosteroids treatment
  • Insufficient understanding
  • Language difficulties
  • Lack of social Insurance
  • Person in emergency situation
  • Person under the protection of justice (tutelage/ curatorship)
  • Persons deprived of their liberty

Study details
    Gestational Diabetes

NCT04451915

University Hospital, Lille

27 June 2026

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