PRECeDe Pilot: Prevention of neonatal respiratory distress with antenatal corticosteroids before elective caesarean section in women with diabetes - a feasibility randomised trial.

Abstract

The PRECeDe Pilot Trial was designed to determine the feasibility of undertaking a multicentre, randomised controlled trial (RCT) to assess the efficacy of antenatal corticosteroids administration within 7 days before elective caesarean section (CS) in women with pre-gestational diabetes (PGDM) or gestational diabetes (GDM). Triple blind, parallel group, placebo-controlled, pilot RCT. Single-centre tertiary maternity hospital in Melbourne, Australia. Pregnant women with PGDM (type 1 or type 2 diabetes) or GDM booked for a planned CS scheduled between 35⁺⁰ and 38⁺⁶  weeks of gestation. Eligible participants were randomised to receive two injections of either betamethasone 11.4 mg or normal saline placebo, 24 hours apart within 7 days before CS scheduled between 35⁺⁰ and 38⁺⁶  weeks of gestation. The proportion of eligible women who consented and were randomised. Australian and New Zealand Clinical Trials Registry ACTRN12619001475134. Of 537 women eligible, 182 were approached and 47 (26%) were recruited. Of these, 22 were allocated to the betamethasone group and 25 were allocated to the placebo group. There were no serious adverse events related to participation. It is feasible to undertake a triple-blind, placebo-controlled RCT investigating the efficacy of antenatal corticosteroids in preventing respiratory morbidity in infants of women with PGDM or GDM who are undergoing an elective CS between 35⁺⁰ and 38⁺⁶  weeks.