Gestational Diabetes: a Cohort Study

University of Sao Paulo General Hospital

Status: Invitation-only

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

Study type: Observational

Funder types: Other

Identifiers

NCT03307486

48868915.9.0000.0068

Details and patient eligibility

About

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.

Enrollment: 1,400 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

1,400 participants in 1 patient group

Gestational diabetes

Description:

Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.