None listed
Conditions
Brief summary
A pilot study of maternal and neonatal outcomes of pregnancies complicated by gestational diabetes, including significant maternal hypoglycaemia and lack of neonatal hypoglycaemia: the main hypothesis is that these will not differ when receiving treatment aimed at achieving ‘very tight’ blood glucose targets, compared with treatment aimed at achieving ‘tight’ blood glucose targets
Interventions
Very tight glycaemic control as monitored by self blood glucose monitoring with a memory glucometer, aiming to keep fasting capillary blood glucose <5.0 mmol/L and 2 hour post prandial capillary blood glucose <6.7 mmol/L until delivery, using diet, exercise, insulin, other drugs, as necessary, and at appropriate doses to maintain the control, under the supervision of an obstetric physician and a diabetes nurse educator
Sponsors
Women's and Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pregnant women with gestational diabetes diagnosed on 75g OGTT: fasting glucose >=5.5 mmol/L and 2h glucose >=8.5 mmol/L, between 12 and 30 weeks gestation, with a singleton or twin pregnancy, not previously diagnosed as diabetic, attending antenatal care at collaborating hospitals, and giving informed written consent
Exclusion criteria
>30+0 weeks gestation, or with triplets or higher order gravidity, or with major active medical disorders (including psychiatric disease requiring antipsychotic medication and inflammatory disorders requiring corticosteroid therapy, but not including chronic hypertension)
Outcome results
None listed