The study of myo-inositol supplements for reducing the risk of gestational diabetes mellitus

INTERVENTION: Randomisation will be performed using computer generated numbers which would allocate participants into either Myo‐inositol or Placebo arms. Both Myo‐inositol and Placebo will have identical packaging prepared at source and supplied through Sidra pharmacy. All research team members and research participants will be blinded to the content of the research packs. The Myo‐inositol pack will contain 2 g of Myo‐inositol whereas the placebo pack will contain a pharmacologically inert substrate, and both arms will have twice daily dosing. Monthly (30 days) supply of the trial packs will be supplied and the research nurse will make scheduled contacts with all participants on a monthly basis, to arrange additional supply of trial packs and check on compliance. These scheduled contacts will be linked to the regular antenatal clinic schedules, so that participants do not have to make extra visits. All participants will have standard antenatal care as per Sidra prenatal care pathway. The Oral Glucose Tolerance test (OGTT) will be performed at 24‐28 weeks as usual per Sidra protocol for routine screening for GDM. All participants will complete at least 12 weeks of intervention/supplementation prior to undertaking the OGTT. Women will be advised to continue using the trial packs regardless of GTT results. Those who are diagnosed as having GDM will have standard antenatal care as per Sidra prenatal care pathway. Participants will be advised to stop study supplements only when admitted in spontaneous labour, for Induction of Labour or Lower Segment Caesarean Section, whichever comes earlier. The trial packs will be sourced from a supplier with CONDITION: Prevention of gestational diabetes in pregnant women ; Pregnancy and Childbirth PRIMARY OUTCOME: The occurrence of GDM measured using Oral Glucose Tolerance Test at 24 ‐ 28 weeks of gestation INCLUSION CRITERIA: 1. All pregnant women booked for prenatal care at Sidra Medicine will be approached regardless of age, language spoken or place for delivery 2. Gestational age less than 16 weeks 3. Capacity to provide informed consent SECONDARY OUTCOME: ; 1. Maternal:; 1.1. Gestational weight gain measured using antenatal maternal records from the first recorded maternal weight and the final maternal weight; 1.2. Need for metformin or insulin therapy measured using antenatal maternal records throughout pregnancy; 1.3. Mode of delivery measured using maternal records at the time of delivery; 1.4. Hypertension in pregnancy measured using maternal records; ; 2. Fetal:; 2.1. Large for Gestational Age at delivery (weight >95th centile for gestation) measured using fetal weight as centile at delivery; 2.2. Small for Gestational Age at delivery (weight <10th centile for gestation) measured using fetal weight as centile at delivery; 2.3. Macrosomia (fetal weight =4000 g at delivery) measured using actual baby weight as centile at delivery; 2.4. Shoulder dystocia and birth injury measured using maternal records at time of delivery; 2.5. Polyhydramnios measured using maternal records from the latest ultrasound report before delivery; 2.6. NICU Admission for >24 h measured using infant records after delivery; 2.7. Neonatal hypoglycaemia requiring intravenous glucose measured using infant records after delivery; 2.8. Preterm delivery (<37 weeks gestation) measured using maternal records at time of delivery; 2.9. Transient tachypnea of the newborn measured using infant records after delivery; 2.10. Respiratory distress syndrome measured using infant records after delivery;