Glycemic profile of pregnancy Pregnancy and Childbirth
Conditions
Interventions
CGM (masked - which means the participant can't see the data) will be performed for a 14-day period on five occasions across pregnancy. These five occasions will occur during routine hospital visits,
Sponsors
University of Leeds
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18-45 years 2. Pregnant women in the first trimester of pregnancy 3. Singleton pregnancy 4. Have one or more of the following risk factors for developing hyperglycaemia in pregnancy: 4.1. BMI >30 kg/m² 4.2. Previous unexplained stillbirth or baby >4.5 kg 4.3. First degree relative with diabetes 4.4. Ethnic minority group (South Asian, Middle-Eastern, Afro-Caribbean)
Exclusion criteria
Exclusion criteria: 1. Women presenting after 14 weeks gestation 2. Type 1 or Type 2 diabetes 3. A previous history of gestational diabetes 4. On metformin therapy for infertility 5. Multiple pregnancy 6. Fetal congenital abnormality 7. Significant co-existent medical or psychiatric conditions 8. Unable to understand English and no translator available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 16/03/2023: The primary maternal outcome is a clinical diagnosis of GDM, and the primary neonatal outcome is Large for Gestational Age (LGA) at birth (>90th centile defined by customised birthweight centile). ______ Previous primary outcome measure: Large for gestational age (>90th centile defined by customised GROW birthweight centile) at birth | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Gestational diabetes diagnosed by oral glucose tolerance test at 26-28 weeks gestation 2. Fetal growth (measured by birthweight; customised growth centiles; neonatal adiposity at birth measured by skin thickness; ultrasound measures of abdominal circumference and estimated fetal weight at 28, 32 and 36 weeks gestation) Additional outcomes collected: 1. Maternal outcomes at end of pregnancy: hypertensive disorders (chronic; gestational; pre-eclampsia); mode of delivery inc. caesarean section; maternal weight gain; maternal length of stay in hospital after delivery, measured using clinical records 2. Neonatal outcomes at end of pregnancy: pregnancy loss <20 weeks; stillbirth; termination; congenital anomaly; preterm births (<37 weeks; <34 weeks) gestational age at delivery; neonatal hypoglycaemia, neonatal ICU admission, birth injury, shoulder dystocia, hyperbilirubinemia, respiratory distress; infant length of stay in hospital after delivery; composite neonatal outcome, measured using clinical records | — |
Countries
England, United Kingdom
Contacts
Public ContactViv Dolby
Outcome results
None listed