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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH ARRAS
RECRUITING
Arras
Hopital Estaing - Chu63 - Clermont Ferrand
RECRUITING
Clermont-ferrand
Hop Claude Huriez Chu Lille
RECRUITING
Lille
Hopital Saint Vincent - Saint Antoine - Lille
RECRUITING
Lille
Chu Nimes Caremeau - Nimes 9
RECRUITING
Nîmes
Hopital Haut-Leveque - Chu - Pessac
RECRUITING
Pessac
Ch Rene Dubos - Pontoise
RECRUITING
Pontoise
Chu Site Sud (Saint Pierre) - St Pierre
RECRUITING
Saint-pierre
Csapa / Hus / Hopital Civil - Strasbourg
RECRUITING
Strasbourg
Hopital de Rangueil Chu Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Anne VAMBERGUE, MD,PhD
anne.vambergue@chru-lille.fr
0320445962
Time Frame
Start Date: 2020-11-30
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 2010
Treatments
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.
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov