Early Gestational Diabetes Mellitus

Sponsor
University Hospital, Lille
Study ID
NCT04451915
Status
Recruiting
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Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • late management strategy — OTHER
    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
  • early management strategy — OTHER
    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

Study Details

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

Key Dates

First listed
Jun 30, 2020
Start date
Nov 30, 2020
Status verified
May 2026
Primary completion
Feb 15, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
2,010 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Early management GDM group
    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
  • Experimental: Late management GDM group
    early management of GDM defined as intensive metabolic treatment (diet, physical activity self-blood glucose monitoring according and/or insulin therapy according to the French guidelines). This intensive treatment will begin after the randomization until delivery.

Primary Outcome Measure

The occurrence of materno-fetal complications [ Time Frame: at delivery ]

Central Contacts

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