Early Gestational Diabetes Mellitus

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    2010
  • sponsor
    University Hospital, Lille
Updated on 28 April 2021

Summary

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

Details
Condition Gestational Diabetes, Diabetes Mellitus, Diabetes Mellitus Types I and II, Diabetes Prevention, Diabetes (Pediatric), Pregnancy Complications, Pregnancy Complications, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric)
Treatment late management strategy, early management strategy
Clinical Study IdentifierNCT04451915
SponsorUniversity Hospital, Lille
Last Modified on28 April 2021

Eligibility

Yes No Not Sure

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

Multiple Pregnancy
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
Refusal to participate in research
Person in emergency situation
Person under the protection of justice (tutelage/ curatorship)
Persons deprived of their liberty
Clear my responses

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