Background Preterm prelabour rupture of membranes (PPROM) is the cause of 40% of all preterm births. Best practice for women who rupture their membranes preterm is not known. The aim of this study is to determine whether immediate delivery or expectant management of women with PPROM at 34–366 weeks gestation is associated with less neonatal and/or maternal morbidity.
Methods The PPROMT Trial is a large, international, multi-centre, randomised controlled trial with 1835 recruits from 65 centres in 11 countries. The primary study outcome is the incidence of neonatal sepsis. Secondary outcomes include severe neonatal morbidity/mortality (sepsis, positive pressure ventilation >24 h or death), perinatal mortality, neonatal respiratory distress syndrome, mode of delivery and duration of hospitalisation for mothers and infants.
Results The trial finished in December 2013, 923 women were randomised to receive early delivery and 912 expectant management. 52 (2.8%) infants had sepsis. 134 (7.3%) had severe neonatal morbidity/mortality, including 6 (0.3%) deaths and 93 (5%) ventilation >24 h. 123 (6.7%) had Respiratory Distress Syndrome. 408 (22.2%) were born by caesarean section. Length of stay (median (IQR)) was 5 (4–8) days for mothers and 5 (3–9) days for infants. Analysis by intention to treat will be presented.
Conclusions There is a significant rate of neonatal and maternal morbidity after maternal PPROM at 34–366. If it can be demonstrated that either early planned birth or expectant management in this clinical situation is associated with less neonatal and/or maternal morbidity this will change current international practice.