NCT03307486Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 12 Oct 2017 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 25 Jul 2017
- Start date
- 17 Sept 2015
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT03307486
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 17 Sept 2015 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- loss to follow up during pregnancy
Who the study is looking for
- 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
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.