The PRECeDe Trial (Prevention of Neonatal Respiratory Distress with Antenatal Corticosteroids before Elective Caesarean Section in Women with Diabetes) is an international randomised controlled trial designed to address an important evidence gap in maternity care. Women with diabetes in pregnancy are more likely to require planned caesarean birth before 39 weeks’ gestation, and their babies are at increased risk of neonatal respiratory morbidity. Despite this, women with diabetes have historically been excluded from many major antenatal corticosteroid trials because of concerns about maternal hyperglycaemia and neonatal hypoglycaemia. As a result, there is limited high-quality evidence to guide clinical care for this growing population.
The PRECeDe research program was specifically developed to ensure that women with diabetes are meaningfully included in high-quality randomised trials. The PRECeDe Pilot Trial demonstrated that women with diabetes and their clinicians considered participation in a placebo-controlled trial acceptable, and confirmed that a rigorous triple-blind randomised trial could be conducted safely and feasibly. The pilot trial also demonstrated strong consumer support for participation and informed the design of the larger international PRECeDe Trial.
The PRECeDe Trial includes women with all types of diabetes who are planning to give birth by caesarean section between 35+0 and 39+6 weeks’ gestation. Funded by the National Health and Medical Research Council (NHMRC), the trial is currently recruiting at 15 sites across Australia and New Zealand, with additional sites commencing in 2026. The trial has been developed with a strong commitment to multidisciplinary collaboration, consumer engagement, and patient-centred research. By intentionally including women who have often been excluded from clinical trials, the PRECeDe Trial aims to generate evidence that improves outcomes for women with diabetes and their babies worldwide.
To learn more about the PRECeDe Trial: PRECeDe Trial Linktree