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| Name | Class |
|---|---|
| University of Chieti | OTHER |
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Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.
The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo control | Diet pills of 400 mcg of acid folic daily |
| |
| D-chiro-inositol / Myo-inositol | Diet sachets 2000 mg myo-inositol and 250 mg d-chiro-inositol and 400 mcg folic acid daily |
| |
| D-chiro-inositol | Diet pills with 500 mg d-chiro-inositol and 400 mcg folic acid daily |
| |
| Myo-inositol | Diet sachets with 2000 mg myo-inositol and 200 mcg folic acid twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-inositol | Dietary Supplement | Dietary control plus Myo-inositol |
|
| Measure | Description | Time Frame |
|---|---|---|
| OGTT result | OGTT is the mainstay of obstetric outcomes in GDM | 24-28 weeks' gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal measurements at third trimester | Centiles of fetal measurements and amniotic fluid volume | 28 weeks |
| Delivery data | Gestational age at delivery Route of delivery Fetal gender Fetal weight (grams and centiles) Neonatal hypoglycemia |
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Inclusion Criteria:
Exclusion Criteria:
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Non obese pregnant women during first trimester of pregnancy with scared fasting glucose (above 92 mg%)
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Celentano, MD | ObGyn Dept University of Chieti | Study Director |
| Barbara Matarrelli, MD | ObGyn Dept Univ of Chieti | Principal Investigator |
| Ester Vitacolonna, MD | Diabetology Dept Univ of Chieti | Study Chair |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| D-chiro-inositol | Dietary Supplement | Dietary control plus D-Chiro-Inositol supplementation |
|
| D-Chiro / Myo-inositol | Dietary Supplement | Dietary control Supplementation with myo and d-chiro inositol |
|
| Placebo | Dietary Supplement | Dietary control plus folic acid 400 mcg daily |
|
| 25-42 weeks gestations' |
| Adverse obstetric outcome | Abortion Preterm delivery Polyhydramnios IUGR Macrosomia Fetal distress Preterm delivery pPROM Neonatal morbility (NICU stay, low glucose levels, etc.) Neonatal mortality Cerebral palsy Route of delivery Dystocia Etc. | from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation) |