Early Gestational Diabetes Mellitus

Официальное название

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

Обзор

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

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• The occurrence of materno-fetal complications [Срок оценки: at delivery]

Вторичные конечные точки (12)

• Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM [Срок оценки: at delivery]
• Need for insulin during pregnancy [Срок оценки: at each 10 days until delivery]
• Metabolic data: Fasting plasma glucose [Срок оценки: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation]
• Metabolic data: HbA1c [Срок оценки: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation]
• Oral Glucose Tolerance Test (OGTT) [Срок оценки: an average at 24 28 weeks of gestation]
• Percent of GDM women in the late GDM management group according to the IADPSG criteria. [Срок оценки: an average at 24 28 weeks of gestation]
• Number of complications in each subgroup of the late GDM management group [Срок оценки: at delivery]
• Neonatal anthropometric parameters [Срок оценки: 6 weeks after delivery]
• Maternal plasma metabolic parameters [Срок оценки: at 6 weeks after delivery]
• Cord blood metabolic parameters [Срок оценки: 6 weeks after delivery]
• Fecal microbiota composition and diversity in early and late GDM management group compared to euglycaemic group and, for the early and late GDM groups, analyzed according to GDM management of their own mothers and in regard of colostrum microbiota [Срок оценки: at 6 weeks after delivery]
• Breast milk composition (nutrients and bacterial community) in early and late GDM management group compared to euglycaemic group [Срок оценки: at 6 weeks after delivery]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 10 центров

• CH ARRAS — Arras
• Hopital Estaing - Chu63 - Clermont Ferrand — Clermont-Ferrand
• Hop Claude Huriez Chu Lille — Lille
• Hopital Saint Vincent - Saint Antoine - Lille — Lille
• Chu Nimes Caremeau - Nimes 9 — Nîmes
• Hopital Haut-Leveque - Chu - Pessac — Pessac
• Ch Rene Dubos - Pontoise — Pontoise
• Chu Site Sud (Saint Pierre) - St Pierre — Saint-Pierre
• … и ещё 2 центра

Идентификаторы

NCT: NCT04451915 · 2017_76 · 2018-A00794-51 · PHRC-17-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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