Gestational Diabetes: a Cohort Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gestational Diabetes, Diabetes, Gestational, Diabetes Mellitus in Pregnancy, Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: loss to follow up during pregnancy
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gestational diabetes<br>Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of type 2 DM after GDM | 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 | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of insulin | To evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy | during pregnancy | 
| Weight at birth | To evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams) | during pregnancy and delivery | 
| Route of delivery | To evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery | during pregnancy and delivery | 
| Neonatal Hypoglycemia | To evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia | during pregnancy and delivery | 
| Obesity in the offspring | To evaluate clinical, ultrasonographic and laboratory factors as tools to predict obesity in the offspring of women with GDM | 10 years | 
| Hypertension in the offspring | To evaluate clinical, ultrasonographic and laboratory factors as tools to predict hypertension in the offspring of women with GDM | 10 years | 
| Body composition | To assess the body composition of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum | during pregnancy, 6 months postpartum and one year after delivery | 
| Physical activity | identify the level of daily physical activity of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum | during pregnancy , 6 months postpartum and 1 year after delivery | 
| Eating habits | to verify the eating habits of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum | during pregnancy, 6 months postpartum and 1 year after delivery | 
| Weight retention | To study association between levels of physical activity and dietary intake and the weight retention in women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum | during pregnancy, 6 months postpartum and 1 year after delivery | 
| Route of delivery vs physical activity | to study association between the level of physical activity in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth) | during pregnancy and delivery | 
| Route of delivery vs eating habits | to study association between the eating habits in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth) | during pregnancy and delivery | 
| Fetal weight at birth vs physical activity | to study association between physical activity in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams) | during pregnancy and delivery | 
| Fetal weight at birth vs eating habits | to study association between eating habits in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams) | during pregnancy and delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes, Type 2 DM after GDM