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
Sponsor study identifier
observational
1,400
1 country
1
Study Start
September 17, 2015
Actual (reported)Primary Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2015
Actual (reported)July 25, 2017
Actual (reported)October 11, 2017
Actual (reported)June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Need of insulin
during pregnancy
Weight at birth
during pregnancy and delivery
Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.
Patients who were diagnosed with gestational diabetes after the adoption of the diagnostic criteria proposed by the IADPSG (June 2011) will be evaluated retrospectively and prospectively in the high-risk prenatal outpatient clinic of the Obstetric Clinic of the Hospital das Clínicas of the Medical School of the University of São Paulo (HCFMUSP), a tertiary teaching hospital in Sao Paulo, Brazil.
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403000, Brazil
First Submitted
July 25, 2017
First Posted
October 11, 2017
Study Start
September 17, 2015
Actual (reported)Primary Completion
June 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Investigating Markers of Energy Metabolism in Pregnant Women With Insulin Resistance
Route of delivery
during pregnancy and delivery
Neonatal Hypoglycemia
during pregnancy and delivery
Obesity in the offspring
10 years
Contact the study team to confirm eligibility.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 12, 2017
Record last verified: 2017-07
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