None listed
Conditions
Brief summary
Gestational diabetes (GDM) is a significant health problem affecting one in every 12 pregnant women or over 5,200 women in New Zealand annually. GDM has a major, negative impact on maternal and perinatal health with lifelong consequences. It is unclear what intensity of glycaemic control during GDM treatment is best for mother and infant. The TARGET randomised Trial will evaluate the implementation of tighter treatment targets for blood sugar control compared with less stringent targets in women with GDM. We will compare the risk of the infant being born large for gestational age, which is strongly associated with significant early life and later health problems. Other relevant outcomes will be assessed. This trial will allow for the sequential implementation of the new, nationally recommended tighter treatment targets for women with GDM and, establish if there are true benefits, without harm, to tighter treatment targets.
Interventions
Tight glycaemic targets for women with gestational diabetes initially and then fasting plasma glucose Less-Than or Equal To 5.0mmol/L; 1 hour postprandial Less-Than or Equal To 7.4mmol/L; 2 hour postprandial Less-Than or Equal To 6.7mmol/L.
These targets will be used by the responsible clinician for glycaemic control following diagnosis of gestational diabetes until the birth of the baby.
Sponsors
University of Auckland, Research Office
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Hospital providing care for women with gestational diabetes diagnosed between 22 weeks' gestation and 34 weeks' gestation.
Exclusion criteria
Women where the fetus has a major anomaly.
Outcome results
None listed