PRECeDe Trial: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes: a Randomised Controlled Trial

Babies born by planned caesarean section — especially before 39 weeks — have a higher risk of breathing difficulties after birth than babies born vaginally. This is because labour itself helps clear fluid from a baby's lungs. A steroid injection given to the mother before birth (called antenatal corticosteroids) has been shown to significantly reduce this risk in the general population, but women with diabetes were deliberately excluded from most of those studies, so it is unclear whether the same benefits apply to them. The PRECeDe Trial is specifically designed to answer this question. Pregnant women with either pre-existing diabetes or gestational diabetes who are planning a caesarean section between 35 and 40 weeks will be randomly assigned to receive either the steroid injection or a placebo before their birth. The main outcome being measured is whether their newborn experiences breathing problems that require medical support. You may be eligible if you are pregnant with one or two babies, have any type of diabetes during pregnancy (pre-gestational or gestational), are planning a caesarean section within the next 7 days, and are between 35 and 40 weeks pregnant. You must not have already received antenatal corticosteroids during this pregnancy or have contraindications to steroids. This is a Phase III trial — meaning it is a definitive, large-scale test of the treatment.