background
We conducted a random ized clinical trial to determine whether treatment of women
with gestational diabetes mellitus reduced the risk of perinatal complications.
methods
We randomly assigned women between 24 and 34 weeks’ gestation who had gestation-
al diabetes to receive dietary advice, blood glucose monitoring, and insulin therapy as
needed (the intervention group) or routine care. Primary outcomes included serious
perinatal complications (defined as death, shoulder dystocia, bone fracture, and nerve
palsy), admission to the neonatal nursery, jaundice requiring phototherapy, induction
of labor, cesarean birth, and maternal anxiety, depression, and health status.