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RECRUITING
NCT04451915
NA

Early Gestational Diabetes Mellitus

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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

Official title: Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2010

Start Date

2020-11-30

Completion Date

2027-06-30

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

OTHER

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

OTHER

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

Locations (10)

CH ARRAS

Arras, France

Hopital Estaing - Chu63 - Clermont Ferrand

Clermont-Ferrand, France

Hop Claude Huriez Chu Lille

Lille, France

Hopital Saint Vincent - Saint Antoine - Lille

Lille, France

Chu Nimes Caremeau - Nimes 9

Nîmes, France

Hopital Haut-Leveque - Chu - Pessac

Pessac, France

Ch Rene Dubos - Pontoise

Pontoise, France

Chu Site Sud (Saint Pierre) - St Pierre

Saint-Pierre, France

Csapa / Hus / Hopital Civil - Strasbourg

Strasbourg, France

Hopital de Rangueil Chu Toulouse

Toulouse, France