2: Multiple courses of antenatal corticosteroids for preterm birth study

Abstract

A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome (RDS) and neonatal death. Trials of weekly vs. single courses of ACS suggest benefits (less respiratory morbidity) but also harm (reduced growth in utero). The aim of this trial was to see if multiple courses of ACS, every 14 days, would be associated with benefits in terms of reduced neonatal morbidity and mortality but without the risk of decreased growth in utero. 1858 women were randomized to receive multiple courses of antenatal corticosteroids vs. placebo every 14 days until 33 6/7 weeks or delivery which ever came first. The primary outcome was a composite of mortality, severe RDS, intraventricular haemorrhage (grade III or IV), periventricular leukomalacia, bronchopulmonary dysplasia or necrotizing enterocolitis. Infants born to women who received multiple courses of ACS incurred similar morbidity and mortality (12.9 % vs. 12.5%) as compared to the single course group 1.04 OR (CI 0.77-1.39 p=0.83). Infants born to women who received multiple courses of ACS weighed less (2216 grams vs. 2330 grams, p=0.0026), were not as long (44.5 cm vs. 45.4 cm, p=0.00075) and had a smaller head circumference (31.1 cm vs. 31.7 cm, p=<0.0001) as compared to those who received a single course of therapy. For women who continue to be at high risk of preterm delivery following an initial course of ACS, multiple courses of ACS, every 14 days until 336/7 weeks or delivery which ever comes first, does not offer additional benefits to their infants and appears to be associated with a decrease in birth weight, birth length and head circumference. Therefore multiple courses of ACS, every 14 days, should not be recommended for women who remain undelivered after their initial course of therapy. (ClinicalTrials.gov number, NCT 00187382)