Status:
UNKNOWN
Efficacy of Treatment for Gestational Diabetes Diagnosed by the IADPSG Criteria.
Lead Sponsor:
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
There is a lack of international uniformity in the approach to the screening and diagnosis of gestational diabetes mellitus (GDM). The new diagnostic criteria by the International Association of Diabe...
Detailed Description
Currently no evidence from randomized clinical trials on the efficacy of treatment of gestational diabetes mellitus (GDM), diagnosed by a single altered value during a 75g oral glucose tolerance test ...
Eligibility Criteria
Inclusion
- Singleton pregnancy between 18-30 week´s gestation
- 75-g oral glucose-tolerance test at 20-30 week´s gestation with only one altered value between: Fasting 92-99 mg/dL
- hour 180-211 mg/dL
- hour 153-177 mg/dL
Exclusion
- Pregestational diabetes (first diagnosed in pregnancy) defined by altered values during 75-g oral glucose-tolerance test above:
- Fasting \>126 mg/dL 2 hour \>200 mg/dL
- Two or more altered values during oral glucose tolerance test above: Fasting 92 mg/dL
- hour 180 mg/dL
- hour 153 mg/dL
- Multiple pregnancy
- Active chronic systemic disease as hyperthyroidism, hearth, hepatic or renal disease, immunological disease as lupus and chronic hypertension
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02708758
Start Date
March 1 2016
End Date
December 1 2021
Last Update
December 28 2021
Active Locations (1)
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1
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Mexico City, Mexico, 11000