PRECEDE Trial: Prevention of neonatal respiratory distress with antenatal corticosteroids prior to elective caesarean section in women with diabetes – A Randomised Trial

Background

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 (CS) after 35 weeks’ gestation. Elective CS (planned CS performed prior to the onset of labour), 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. Moreover, women with diabetes are more likely to give birth by caesarean section and to require birth at earlier gestations compared with women who do not have diabetes, and their infants are more likely to have breathing problems because they are more likely to lack a lining substance in their lungs called “surfactant” that is required to prevent the airspaces in the lung from collapsing after birth. Further research in women with diabetes during pregnancy is urgently needed as these women and their infants potentially have the most to gain from this intervention, if it is indeed effective.

Aim

To determine whether administering antenatal corticosteroids to women with either pre-gestational or gestational diabetes who plan to give birth by elective CS between 35+0 weeks and 39 +6 weeks’ gestation reduces the rate of neonatal respiratory morbidity requiring admission to the neonatal nursery and any form of respiratory support (e.g. intermittent positive pressure via an endotracheal tube, nasal continuous positive airway pressure (CPAP), Hi- or Lo-flow oxygen/air mixture, or increased ambient oxygen delivered into an incubator) for ≥60 minutes at any time following birth.

Progress

Recruitment to commence once site approval gained.

Research Team: Kate Jarrett, Jasmine Wood, Helen Kay, Gabby Rowsell, Bianca Ryan, Dr Shannyn Rosser, Dr Matthew Daly