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The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myo-inositol powder | Experimental |
| |
| Myo-inositol soft gel capsules | Experimental |
| |
| Folic acid | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inositol + folic acid | Dietary Supplement | 2000 mg of inositol+200mcg of folic acid; 2 per diem |
|
| Measure | Description | Time Frame |
|---|---|---|
| OGTT | The diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pregnant women with gestational diabetes | ||
| Number of pregnant women requiring insulin treatment | ||
| Weight gain at the end of pregnancy |
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Inclusion Criteria:
60 women in their first trimester of pregnancy affected by one or more of the following risk factors:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vittorio Unfer | Contact | vunfer@gmail.com | ||
| Gianfranco Carlomagno | Contact | gianfranco.carlomagno@agunco.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGUNCO | Recruiting | Rome | 00155 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19800728 | Background | Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2. | |
| 21414183 | Background | Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| inositol + folic acid | Dietary Supplement | 600 mg of inositol + 200mcg of folic acid; 2 cp per diem |
|
| Folic Acid | Drug | Folic Acid 400mcg; 1 cp/die |
|
| Number of newborn infants whose weight is more than 4000 g |
| Number of newborn infants requiring Neonatal Intensive Care (NIC) |
| 36790138 | Derived | Motuhifonua SK, Lin L, Alsweiler J, Crawford TJ, Crowther CA. Antenatal dietary supplementation with myo-inositol for preventing gestational diabetes. Cochrane Database Syst Rev. 2023 Feb 15;2(2):CD011507. doi: 10.1002/14651858.CD011507.pub3. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011622 |
| Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |