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Efficacy of Myo-inositol in Preventing Gestational Diabetes in High-risk Pregnant Women

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01511835
Enrollment
Unknown
Registered
2012-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

diabetes, pregnancy, myo-inositol

Brief summary

The aim of this study is to evaluate the efficacy of myo-inositol in preventing gestational diabetes in high risk pregnant women.

Interventions

DIETARY_SUPPLEMENTinositol + folic acid

2000 mg of inositol+200mcg of folic acid; 2 per diem

DRUGFolic Acid

Folic Acid 400mcg; 1 cp/die

Sponsors

AGUNCO Obstetrics and Gynecology Centre
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years

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

Design outcomes

Primary

MeasureTime frameDescription
OGTTThe diagnostic 75g oral glucose tolerance test (OGTT) is performed between 24 and 28 weeks of gestation.

Secondary

MeasureTime frame
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)

Countries

Italy

Contacts

Primary ContactVittorio Unfer
vunfer@gmail.com
Backup ContactGianfranco Carlomagno
gianfranco.carlomagno@agunco.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026