PRECeDe Pilot: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes - A Feasibility Randomised Trial

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Administration of antenatal corticosteroids to women prior to preterm birth has been one of the greatest success stories of modern pregnancy and newborn care. Multiple studies have demonstrated a reduction in the rate of breathing problems in newborn babies after this treatment. More recently, several studies have reported benefits when antenatal corticosteroids are given to women who give birth by elective caesarean section after 35 weeks. Elective CS, as opposed to vaginal birth (or even CS in labour) is associated with greater risks of breathing problems in newborn infants and this results in longer hospital stays and separation from the mother. Women with diabetes were specifically excluded from the studies that have demonstrated improvements in the rate of newborn breathing problems, hence, whether these benefits are the same for infants born to women with diabetes is uncertain. Further research in the subgroup of women with diabetes during pregnancy is urgently needed. This study has been designed to determine the feasibility of undertaking a much larger multicentre, randomised, placebo controlled trial to investigate the outcomes for the mother and baby following antenatal administration of corticosteroids within 7 days prior to elective CS in women with pre-gestational or gestational diabetes. A sample size of 2200 participants will be required for the larger trial. In order to determine the feasibility of such a large study and ensure the collection of appropriate outcome data, we are undertaking a smaller pilot feasibility trial to determine patient and clinician acceptability for such a trial.