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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


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

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