Gestational Diabetes: a Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes, Diabetes, Gestational, Diabetes Mellitus in Pregnancy, Diabetes Mellitus, Type 2. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Occurrence of type 2 DM after GDM [Time frame: 10 years]
Secondary outcome measures (12)
- Need of insulin [Time frame: during pregnancy]
- Weight at birth [Time frame: during pregnancy and delivery]
- Route of delivery [Time frame: during pregnancy and delivery]
- Neonatal Hypoglycemia [Time frame: during pregnancy and delivery]
- Obesity in the offspring [Time frame: 10 years]
- Hypertension in the offspring [Time frame: 10 years]
- Body composition [Time frame: during pregnancy, 6 months postpartum and one year after delivery]
- Physical activity [Time frame: during pregnancy , 6 months postpartum and 1 year after delivery]
- Eating habits [Time frame: during pregnancy, 6 months postpartum and 1 year after delivery]
- Weight retention [Time frame: during pregnancy, 6 months postpartum and 1 year after delivery]
- Route of delivery vs physical activity [Time frame: during pregnancy and delivery]
- Route of delivery vs eating habits [Time frame: during pregnancy and delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo
Identifiers
NCT: NCT03307486 · 48868915.9.0000.0068