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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus, Type 2; Gestational Diabetes; Diabetes, Gestational; Diabetes Mellitus in Pregnancy

• Study Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gestational diabetes; Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2015
• Primary Completion (Anticipated): June 1, 2030
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Gestational diabetes; Type 2 DM after GDM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 48868915.9.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No