Gestational diabetes Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
This study design is a randomised controlled double-blind trial of a nutritional intervention. Overweight or obese women with gestational diabetes will be randomly allocated to receive either a standa
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with GDM diagnosed at 20 to 30+6 weeks’ gestation using a standard clinical 75g OGTT in accordance with the guidelines of the National Institute of Health and Care Excellence (NICE) 2. The NICE criteria state that the diagnosis of gestational diabetes will be made with one or more glucose concentrations during the OGTT of: 2.1. >5.6 mmol/l in the fasting state 2.2 >7.8 mmol/l 2 hours after 75 g glucose 3. Pre-pregnancy overweight or obesity (BMI >25 kg/m2) 4. A ultrasound-confirmed viable singleton pregnancy 5. Planned antenatal care at the same centre or a different study centre throughout their pregnancy (ie: not planning to move away from the region before delivery)
Exclusion criteria
Exclusion criteria: 1. Evidence of multiple pregnancy on ultrasound 2. Evidence of severe congenital anomaly on ultrasound 3. Patient planning to terminate the pregnancy for any reason 4. Significant pre-pregnancy diseases or comorbidities which increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (48 mmol/mol 8. Medications at the time of the OGTT which may interfere with the results of the OGTT (for example, steroids, immunosuppressants, certain antipsychotics) 9. Estimated fetal weight 5% pre-pregnancy weight during pregnancy, prior to 28 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neonatal primary outcome measure: Standardised birth weight (standardised for infant gender and gestational age at delivery); Timepoint(s): birth/36 weeks gestation - from hospital data at V3 and birth Maternal primary outcome measure: Maternal weight change (28-36 weeks), measured using Seca scales at V1 and V3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal secondary outcome measures: 1. Large for gestational age (using local, national and international centiles and customised centiles) at birth 2. Small for gestational age (using local, national and international centiles and customised centiles) at birth 3. Cord blood C-peptide measured using Diasorin liaison method at birth 4. Cord blood glucose measured using Hexokinase method on Siemen's analyser at birth 5. Amniotic fluid glucose measured using Hexokinase method on Siemen's analyser at birth 6. Neonatal anthropometry (length, weight, abdominal circumference, head circumference, skinfold thickness, mid upper arm circumference) measured using tape measure, Seca scales, Holtain calipers at birth and V4 7. Neonatal body composition measured using Peapod device at birth/V4 8. Neonatal hypoglycaemia (defined as a low blood glucose requiring intravenous dextrose) from hospital data at V4 9. Neonatal admission to the neonatal intensive care unit (NICU) from hospital data at V4 10. Neonatal feeding type on discharge from hospital, from hospital data, maternal questionnaire at V4 11. Neonatal nasogastric feeding from hospital data at V4 12. Duration of neonatal admission from hospital data at V4 13. Neonatal jaundice requiring phototherapy from hospital data at V4 14. Preterm delivery from hospital data at birth 15. Estimated gestational age at birth from hospital data, dataset calculation at birth 16. Apgar scores from hospital data at birth Maternal secondary outcome measures: 1. Maternal weight and related measurements at 32 and 36 weeks and postpartum measured using Seca scales, Harpenden calipers, tape measure at V1, V2, V3 and V4 2. Maternal weight measured using Seca scales at V1, V2, V3 and V4 3. Maternal weight change (baseline to 32 weeks and 32 to 36 weeks) using dataset formula calculation at V3 4. Maternal BMI from dataset formula calculation at V1, V3 and V4 5. Maternal weight change (grams per week) from dataset formula calculation at V4 6. Velocit | — |
Countries
England, United Kingdom
Outcome results
None listed