Prevention of Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title: Feasibility of a Lifestyle Intervention in Early Risk Pregnancy in Preventing Deterioration in Glucose Tolerance?

Status Completed

Clinical Trial Summary

Gestational diabetes mellitus (GDM)is a major health problem

• growing prevalence of obesity

• the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

• feasibility of an early intervention

• glucose tolerance at weeks 26-28

Clinical Trial Description

1. A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12

1. voluntary women in early pregnancy (n=96)

2. 54 high risk mothers were randomized

• lifestyle intervention group (n=27)

• close follow-up (n=27)

2. An OGTT was performed again at weeks 26-28

• the lifestyle intervention group (n=27)

• the close follow-up group (n=27)

• other high-risk women of the early care group (n=42)who were not randomized

3. An OGTT was also performed at weeks 26-28 in two neighboring municipalities

• a standard care high-risk group(n=171)who did not undergo early intervention

4. Primary outcomes

• number of at risk participants developing GDM during pregnancy in the two arms

5. Secondary outcomes

• the effect of intervention on fetal growth ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

• NCT number: NCT01130012
• Study type: Interventional
• Source: Kuopio University Hospital
• Status: Completed
• Phase: N/A
• Start date: April 2005
• Completion date: December 2006