Prevention of gestational diabetes in pregnant women Pregnancy and Childbirth
Conditions
Interventions
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 packagin
Sponsors
Sidra Medical and Research Center
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Pre-gestational diabetes 2. Booking fasting glucose of =5.1 mmol/l (92 mg/dl) 3. Women on steroids during pregnancy 4. Women using metformin for any other disorder e.g. PCOS 5. Women taking Myo-inositol as part of any supplementation 6. Cancer not in remission 7. Women who lack the capacity to provide informed consent 8. Women who had bariatric surgery 9. Involvement in another interventional trial 10. Polyhydramnios (this is a very unlikely finding before 16 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of GDM measured using Oral Glucose Tolerance Test at 24 - 28 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Countries
Qatar
Outcome results
None listed