Clinical trial NCT03307486: Gestational Diabetes: a Cohort Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gestational Diabetes
Diabetes, Gestational
Diabetes Mellitus in Pregnancy
Diabetes Mellitus, Type 2
Keywords: Gestational diabetes
Type 2 DM after GDM
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 1400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of type 2 DM after GDM
timeFrame: 10 years
Secondary outcomes:
measure: Need of insulin
timeFrame: during pregnancy
measure: Weight at birth
timeFrame: during pregnancy and delivery
measure: Route of delivery
timeFrame: during pregnancy and delivery
measure: Neonatal Hypoglycemia
timeFrame: during pregnancy and delivery
measure: Obesity in the offspring
timeFrame: 10 years
measure: Hypertension in the offspring
timeFrame: 10 years
measure: Body composition
timeFrame: during pregnancy, 6 months postpartum and one year after delivery
measure: Physical activity
timeFrame: during pregnancy , 6 months postpartum and 1 year after delivery
measure: Eating habits
timeFrame: during pregnancy, 6 months postpartum and 1 year after delivery
measure: Weight retention
timeFrame: during pregnancy, 6 months postpartum and 1 year after delivery
measure: Route of delivery vs physical activity
timeFrame: during pregnancy and delivery
measure: Route of delivery vs eating habits
timeFrame: during pregnancy and delivery
measure: Fetal weight at birth vs physical activity
timeFrame: during pregnancy and delivery
measure: Fetal weight at birth vs eating habits
timeFrame: during pregnancy and delivery
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
References: