Status:
COMPLETED
Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia
Lead Sponsor:
UPECLIN HC FM Botucatu Unesp
Conditions:
Gestational Diabetes Mellitus
Pregestational Diabetes Mellitus
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with increased perinatal and maternal complications. The most serious maternal complication is the risk of develop...
Eligibility Criteria
Inclusion
- Patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. Patients should have one of the four criteria as following:
- Patients with positive screening for GDM presenting a TTG of 75 g and one of the values below:
- fasting glucose ≥ 92;
- 1h ≥ 180; or
- 2h ≥ 153 will be considered gestational diabetes mellitus (GDM) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. If the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or
- Patients with pre gestational diabetes mellitus type 1 or 2; or
- Patients with positive screening for GDM and presenting normal TTG of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/ ( Rudge et al,1990).
- Normal TTG and an abnormal glycemic profile will be considered as mild gestational hyperglycemia
- Patient provided written informed consent.
Exclusion
- Twin pregnancy diagnosed until the date of randomization or;
- Fetal malformation diagnosed until the date of randomization.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01441518
Start Date
May 1 2010
End Date
November 1 2013
Last Update
July 8 2015
Active Locations (1)
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1
Faculdade de Medicina de Botucatu, Universidade Estadual Paulista
Botucatu, São Paulo, Brazil, 18618-970