Набор по приглашению NCT03307486

Gestational Diabetes: a Cohort Study

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Gestational Diabetes, Diabetes, Gestational, Diabetes Mellitus in Pregnancy, Diabetes Mellitus, Type 2. Базовые параметры: Без ограничений · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Первичные конечные точки

Occurrence of type 2 DM after GDM [Срок оценки: 10 years]

Вторичные конечные точки (12)

Need of insulin [Срок оценки: during pregnancy]
Weight at birth [Срок оценки: during pregnancy and delivery]
Route of delivery [Срок оценки: during pregnancy and delivery]
Neonatal Hypoglycemia [Срок оценки: during pregnancy and delivery]
Obesity in the offspring [Срок оценки: 10 years]
Hypertension in the offspring [Срок оценки: 10 years]
Body composition [Срок оценки: during pregnancy, 6 months postpartum and one year after delivery]
Physical activity [Срок оценки: during pregnancy , 6 months postpartum and 1 year after delivery]
Eating habits [Срок оценки: during pregnancy, 6 months postpartum and 1 year after delivery]
Weight retention [Срок оценки: during pregnancy, 6 months postpartum and 1 year after delivery]
Route of delivery vs physical activity [Срок оценки: during pregnancy and delivery]
Route of delivery vs eating habits [Срок оценки: during pregnancy and delivery]

Критерии участия

Критерии включения

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