Prevention of Gestational Diabetes
- Conditions
- Gestational Diabetes
- Registration Number
- NCT01130012
- Lead Sponsor
- Kuopio University Hospital
- Brief 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
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 440
- high risk for gestational diabetes
- fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT <7.8 mmol/l
- normal glucose tolerance at weeks 8-12
- gestational diabetes at weeks 8-12
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of at risk participants developing GDM during pregnancy
- Secondary Outcome Measures
Name Time Method The effect of intervention on fetal growth