Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women
Phase 4
- Conditions
- Gestational Diabetes
- Interventions
- Dietary Supplement: inositol + folic acid
- Registration Number
- NCT01511835
- Lead Sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Brief Summary
The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
60 women in their first trimester of pregnancy affected by one or more of the following risk factors:
- Glycemia levels > 92 mg/dl
- BMI > 30
- At least a parent or a brother (or sister)affected by diabetes
- Pre-existing pregnancy with gestational diabetes
Exclusion Criteria
- Pregnant women affected by pregestational diabetes
- Twin pregnancy
- Patients affected by pre-existing diseases in pregnancy (diabetes excluded)
- Patients affected by chronic disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Myo-inositol powder inositol + folic acid - Myo-inositol soft gel capsules inositol + folic acid - Folic acid Folic Acid -
- Primary Outcome Measures
Name Time Method OGTT The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.
- Secondary Outcome Measures
Name Time Method Number of pregnant women with gestational diabetes Number of pregnant women requiring insulin treatment Weight gain at the end of pregnancy Number of newborn infants whose weight is more than 4000 g Number of newborn infants requiring Neonatal Intensive Care (NIC)
Trial Locations
- Locations (1)
AGUNCO
🇮🇹Rome, Italy