Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,010
- 试验地点
- 10
- 主要终点
- The occurrence of materno-fetal complications
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: early management strategy (Other)
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.
干预措施: late management strategy (Other)
结局指标
主要结局
The occurrence of materno-fetal complications
时间窗: at delivery
Composite endpoint defined by Large for Gestational Age (LGA) (defined by birth weight ≥90th percentile, adjusted for gestational age, sex, maternal BMI, parity, ethnicity) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth traumatisms
次要结局
- Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM(at delivery)
- Metabolic data: Fasting plasma glucose(at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation)
- Need for insulin during pregnancy(at each 10 days until delivery)
- Metabolic data: HbA1c(at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation)
- Oral Glucose Tolerance Test (OGTT)(an average at 24 28 weeks of gestation)
- Percent of GDM women in the late GDM management group according to the IADPSG criteria.(an average at 24 28 weeks of gestation)
- Number of complications in each subgroup of the late GDM management group(at delivery)
- Neonatal anthropometric parameters(6 weeks after delivery)
- Maternal plasma metabolic parameters(at 6 weeks after delivery)
- Cord blood metabolic parameters(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(at 6 weeks after delivery)
- Breast milk composition (nutrients and bacterial community) in early and late GDM management group compared to euglycaemic group(at 6 weeks after delivery)