Fetal and Maternal Repercussions of Gestational Diabetes After the Adoption of the Diagnostic Criteria Proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG): a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Occurrence of type 2 DM after GDM
研究概览
简要总结
Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its occurrence implies an increased risk of maternal and fetal complications and, therefore, its diagnosis and treatment are extremely important. Since the adoption of the new diagnostic criteria proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity, adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal binomial, since gestations with satisfactory glycemic control can also present complications related to the disease and increased risk of type 2 DM in the long term. The present study aims to investigate factors associated with the need for insulin use, the occurrence of perinatal complications, nutritional status, physical activity and weight retention one year after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women diagnosed with GDM according to the current criteria suggested by the IADPSG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •single pregnancies
- •absence of glucose intolerance prior to gestation (defined by prior diagnosis of polycystic ovarian syndrome or fasting glycemia ≥100mg / dl or 2hr post-overload with 75g glucose ≥ 140mg / dL or glycated hemoglobin ≥ 5.7% previously to pregnancy)
- •absence of chronic use of glucocorticoids or antiretroviral drugs for HIV virus, given its diabetogenic effect and potential confounding
- •diagnosis of GDM according to diagnostic criteria proposed by the IADPSG, namely: initial fasting blood glucose ≥ 92mg / dL OR oral glucose tolerance test of 75g with fasting ≥ 92mg / dL or after1h ≥ 180mg / dL or after 2h ≥ 153mg / dL
- •Agreement with the informed consent term for patients who will be followed prospectively
- •Agreement with the free and informed consent term for recall and reassessment of the patients identified in the retrospective analysis of the data
排除标准
- •loss to follow up during pregnancy
结局指标
主要结局
Occurrence of type 2 DM after GDM
时间窗: 10 years
To evaluate clinical, nutritional and laboratory factors as tools to predict the diagnosis of type 2 DM, carbohydrate intolerance or postpartum metabolic syndrome in women who had GDM
次要结局
- Need of insulin(during pregnancy)
- Obesity in the offspring(10 years)
- Body composition(during pregnancy, 6 months postpartum and one year after delivery)
- Route of delivery vs physical activity(during pregnancy and delivery)
- Neonatal Hypoglycemia(during pregnancy and delivery)
- Weight retention(during pregnancy, 6 months postpartum and 1 year after delivery)
- Route of delivery vs eating habits(during pregnancy and delivery)
- Eating habits(during pregnancy, 6 months postpartum and 1 year after delivery)
- Route of delivery(during pregnancy and delivery)
- Hypertension in the offspring(10 years)
- Physical activity(during pregnancy , 6 months postpartum and 1 year after delivery)
- Fetal weight at birth vs physical activity(during pregnancy and delivery)
- Weight at birth(during pregnancy and delivery)
- Fetal weight at birth vs eating habits(during pregnancy and delivery)