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Enrolling by Invitation

NCT Number: NCT03307486

Gestational Diabetes: a Cohort Study

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes Mellitus in Pregnancy Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of type 2 DM after GDM

    Time frame: 10 years

    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

Secondary outcomes

  1. Need of insulin

    Time frame: during pregnancy

    To evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy

  2. Weight at birth

    Time frame: during pregnancy and delivery

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams)

  3. Route of delivery

    Time frame: during pregnancy and delivery

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery

  4. Neonatal Hypoglycemia

    Time frame: during pregnancy and delivery

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia

  5. Obesity in the offspring

    Time frame: 10 years

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict obesity in the offspring of women with GDM

  6. Hypertension in the offspring

    Time frame: 10 years

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict hypertension in the offspring of women with GDM

  7. Body composition

    Time frame: during pregnancy, 6 months postpartum and one year after delivery

    To assess the body composition of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

  8. Physical activity

    Time frame: during pregnancy , 6 months postpartum and 1 year after delivery

    identify the level of daily physical activity of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

  9. Eating habits

    Time frame: during pregnancy, 6 months postpartum and 1 year after delivery

    to verify the eating habits of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

  10. Weight retention

    Time frame: during pregnancy, 6 months postpartum and 1 year after delivery

    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

  11. Route of delivery vs physical activity

    Time frame: during pregnancy and delivery

    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)

  12. Route of delivery vs eating habits

    Time frame: during pregnancy and delivery

    to study association between the eating habits in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)

  13. Fetal weight at birth vs physical activity

    Time frame: during pregnancy and delivery

    to study association between physical activity in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)

  14. Fetal weight at birth vs eating habits

    Time frame: during pregnancy and delivery

    to study association between eating habits in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2030
Study completion
2030
First posted
Oct 11, 2017
Registry last updated
Oct 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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