Mild gestational diabetes mellitus Nutritional, Metabolic, Endocrine Mild gestational diabetes mellitus
Conditions
Interventions
Participants who are diagnosed as gestational diabetes and fulfilled the inclusion and exclusion criteria will be recruited. Blood samples for HbA1c are obtained and analysed by centre’s laboratory.
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 11/12/2017: 1. Aged 18 to 45 years 2. Singleton pregnancy 3. Gestational age at recruitment 16-30 weeks 4. Confirmed GDM: Fasting plasma glucose = 5.1 mmol/L and/or the 2-hour = 7.8 mmol/L by 75g OGTT 5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial = 5.3, post prandial 1 hour of = 7.8 or post prandial 2 hours of = 6.7 mmol/L 6. Not on any hypoglycaemic drug treatment Previous inclusion criteria: 1. Aged 18 to 45 years 2. Singleton pregnancy 3. Gestational age at recruitment 16-30 weeks 4. Confirmed GDM: Fasting plasma glucose = 5.1 mmol/L and/or the 2-hour = 7.8 mmol/L by 75g OGTT = 16 weeks of pregnancy 5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial = 5.3, post prandial 1 hour of = 7.8 or post prandial 2 hours of = 6.7 mmol/L 6. Not on any hypoglycaemic drug treatment
Exclusion criteria
Exclusion criteria: 1. Any contraindication to metformin 2. History of prepregnant hyperglycaemia 2.1. Type 2 diabetes, 2.2. Impaired glucose tolerance 2.3. Fasting glycaemia 3. Diagnostic 75g OGTT: fasting plasma glucose = 7 or 2-hour glucose = 11.1 mmol/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c is measured using blood samples at baseline and 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability is measured using a symptom questionnaire at four weeks after recruitment and at 36 weeks gestation 2. Open label metformin use in pregnancy is measured by checking participants’ hospital records after delivery 3. Insulin use in pregnancy is measured by checking participants’ hospital records after delivery 4. Pregnancy induced hypertension is defined as blood pressure more than 140/90mmHg on 2 occasions with 4 hours apart after 20 weeks of gestation and established by checking participants’ hospital records after delivery 5. Gestational age at delivery (preterm labour < 37 weeks) 6. Intervention to delivery interval is measured by checking participants’ hospital records after delivery 7. Induction of labour is measured by checking participants’ hospital records after delivery 8. Epidural analgesia in labour is measured by checking participants’ hospital records after delivery 9. Mode of delivery 9.1. Indication for Caesarean delivery 10. Blood loss at delivery is measured as: 10.1. Postpartum haemorrhage = 500 ml 10.2. Major postpartum haemorrhage = 1000 ml 11. Third or fourth degree perineal tear as reported at birth 12. Reported shoulder dystocia 13. Birth weight is measured by checking participants’ hospital records after delivery 14. Placenta weight is measured by checking participants’ hospital records after delivery 15. Umbilical cord arterial pH at birth 16. Neonatal birth injury 17. Neonatal jaundice 18. Neonatal admission and indication | — |
Countries
Malaysia
Outcome results
None listed