women with GDM (gestational diabetes), blinded to the targets in use, were eligible
all hospitals initially used less tight targets (fasting plasma glucose (FPG) <5.5 mmol/L (<99 mg/dL), 1-hour <8.0 mmol/L (<144 mg/dL), 2 hour postprandial <7.0 mmol/L (<126 mg/dL)) and every 4 months, 2 hospitals moved to use tighter targets (FPG <=5.0 mmol/L (<=90 mg/dL), 1-hour <=7.4 mmol/L (<=133 mg/dL), 2 hour postprandial <=6.7 mmol/L) (<=121 mg/dL)
primary outcome was large for gestational age
secondary outcomes assessed maternal and infant health
analyses were by intention to treat
Study results
data were collected from 1,100 women with GDM (1,108 infants);
598 women (602 infants) used the tighter targets and 502 women (506 infants) used the less tight targets
rate of large for gestational age was similar between the treatment target groups (88/599, 14.7% versus 76/502, 15.1%; adjusted relative risk [adjRR] 0.96, 95% confidence interval [CI] 0.66 to 1.40, P = 0.839)
composite serious health outcome for the infant of perinatal death, birth trauma, or shoulder dystocia was apparently reduced in the tighter group
secondary outcomes for the woman showed an apparent increase for the composite serious health outcome that included major haemorrhage, coagulopathy, embolism, and obstetric complications in the tighter group
conclusions
tighter glycaemic targets in women with GDM compared to less tight targets did not reduce the risk of a large for gestational age infant, but did reduce serious infant morbidity, although serious maternal morbidity was increased. These findings can be used to aid decisions on the glycaemic targets women with GDM should use
Reference:
Crowther CA, Samuel D, Hughes R, Tran T, Brown J, Alsweiler JM, et al. (2022) Tighter or less tight glycaemic targets for women with gestational diabetes mellitus for reducing maternal and perinatal morbidity: A stepped-wedge, cluster-randomised trial. PLoS Med 19(9): e1004087. https://doi.org/10.1371/journal.pmed.1004087
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