Nutritional, Metabolic, Endocrine: Diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
A collaborative, open-label, randomised controlled trial with participants allocated to either standard antenatal care or CGMS which will be performed monthly in addition to standard care.
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Target total across all sites = 120. Inclusion: All women with pre-existing diabetes attending Ipswich or Norwich antenatal diabetes centre.
Exclusion criteria
Exclusion criteria: None other than serious medical or psychological co-morbidity which would interfere with the subjects ability to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infants: 1. Perinatal outcome assessed will be gestational age 2. Body weight 3. Respiratory distress (1 and 5 minute apgar scores) 4. Admission to special care baby unit with hypoglycaemia or hyperbilirubinaemia 5. Cord blood measurements of adiposity and hyperinsulineamia Mothers: 1. Glycaemic control 2. Frequency and severity of hypoglycaemia 3. Presence and /or progression of retinopathy 4. Mode of delivery 5. Delivery related complications 6. Diabetes related distress questionnaire 7. Individually generated index of quality of life measure | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed