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Gestational Diabetes: a Cohort Study

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03307486
Enrollment
1400
Registered
2017-10-11
Start date
2015-09-17
Completion date
2030-12-31
Last updated
2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational, Diabetes Mellitus in Pregnancy, Diabetes Mellitus, Type 2, Gestational Diabetes

Keywords

Gestational diabetes, Type 2 DM after GDM

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.

Interventions

None listed

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of type 2 DM after GDM10 yearsTo 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

Secondary

MeasureTime frameDescription
Weight at birthduring pregnancy and deliveryTo evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams)
Route of deliveryduring pregnancy and deliveryTo evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery
Neonatal Hypoglycemiaduring pregnancy and deliveryTo evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia
Obesity in the offspring10 yearsTo evaluate clinical, ultrasonographic and laboratory factors as tools to predict obesity in the offspring of women with GDM
Hypertension in the offspring10 yearsTo evaluate clinical, ultrasonographic and laboratory factors as tools to predict hypertension in the offspring of women with GDM
Body compositionduring pregnancy, 6 months postpartum and one year after deliveryTo assess the body composition of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum
Need of insulinduring pregnancyTo evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy
Eating habitsduring pregnancy, 6 months postpartum and 1 year after deliveryto verify the eating habits of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum
Weight retentionduring pregnancy, 6 months postpartum and 1 year after deliveryTo 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
Route of delivery vs physical activityduring pregnancy and deliveryto study association between the level of physical activity in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)
Route of delivery vs eating habitsduring pregnancy and deliveryto study association between the eating habits in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)
Fetal weight at birth vs physical activityduring pregnancy and deliveryto study association between physical activity in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)
Fetal weight at birth vs eating habitsduring pregnancy and deliveryto study association between eating habits in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)
Physical activityduring pregnancy , 6 months postpartum and 1 year after deliveryidentify the level of daily physical activity of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026