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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03307486
Other study ID # 48868915.9.0000.0068
Secondary ID
Status Enrolling by invitation
Phase N/A
First received July 25, 2017
Last updated October 11, 2017
Start date September 17, 2015
Est. completion date December 2030

Study information

Verified date July 2017
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1400
Est. completion date December 2030
Est. primary completion date June 2030
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
Brazil Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Need of insulin To evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy during pregnancy
Secondary Weight at birth To evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams) during pregnancy and delivery
Secondary Route of delivery To evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery during pregnancy and delivery
Secondary Neonatal Hypoglycemia To evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia during pregnancy and delivery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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