IRCT20120826010664N4.

Study name	The effect of myoinositol supplementation on the prevention of gestational diabetes mellitus in high‐risk women
Methods	Study type: randomised, multi‐center, clinical trial with parallel groups
Participants	Inclusion criteria: BMI > 30, family history of type 2 diabetes, previous history of gestational diabetes, glucosoria, glucose metabolism disorder, and history of infant macrosomia. Exclusion criteria: history of diabetes mellitus, multiple pregnancies, acute infection during pregnancy, impaired OGTT in first‐trimester routine tests. Target sample size: 276 women
Interventions	Intervention: 2 g of myo‐inositol + 200 mcg of folic acid twice per day from 14 to 28 weeks gestation. Control: 200 mcg folic acid twice per day
Outcomes	Primary outcome: rate of gestational diabetes and other side effects of gestational diabetes
Starting date	Expected recruitment start date: 20 February 2019
Contact information	Dr Reihaneh Pirjani (Associate Professor) Tehran University of Medical Sciences pirjani@razi.tums.ac.ir
Notes	The study is not blinded and it states that placebo is not used. Registration date: 08 May 2019            Last update: 08 May 2019