Informations générales (source: ClinicalTrials.gov)
Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial (LEMA_GDM)
Interventional
N/A
University Hospital, Lille (Voir sur ClinicalTrials)
novembre 2020
décembre 2023
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | CAMPINOS | 04/07/2024 11:05:01 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH ARRAS - Arras - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu Nimes Caremeau - Nimes 9 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Chu Site Sud (Saint Pierre) - St Pierre - Saint-Pierre - France | Contact (sur clinicalTrials) | ||||
| Csapa / Hus / Hopital Civil - Strasbourg - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hop Claude Huriez Chu Lille - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital de Rangueil Chu Toulouse - 31300 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hopital Estaing - Chu63 - Clermont Ferrand - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Hopital Haut-Leveque - Chu - Pessac - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Vincent - Saint Antoine - Lille - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
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
- 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
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