Status:
ENROLLING_BY_INVITATION
Gestational Diabetes: a Cohort Study
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Gestational Diabetes
Diabetes, Gestational
Eligibility:
FEMALE
Brief Summary
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 tre...
Eligibility Criteria
Inclusion
- 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
- loss to follow up during pregnancy
Key Trial Info
Start Date :
September 17 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT03307486
Start Date
September 17 2015
End Date
December 1 2030
Last Update
October 12 2017
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403000