The use of dexamethasone in women with preterm premature rupture of membranes - A multicentre, double-blind, placebo-controlled, randomised trial

Objective. To assess whether administration of dexamethasone in women with preterm premature rupture of membranes (PPROM) has an effect on the prevale nce of maternal sepsis, neonatal respiratory distress syndrome (RDS), perin atal mortality and neonatal sepsis in a developing country. Setting. Six public hospitals in South Africa that deal mainly with indigen t women. Method. A multicentre, double-blind, placebo-controlled, randomised trial w as performed on women with PPROM and fetuses of 28 - 34 weeks' gestation or clinically estimated fetal weight between 1 000 and 2 000 g if the gestati onal age was unknown. Women were randomised to receive either dexamethasone 24 mg intramuscularly or placebo in two divided doses 24 hours apart. All women received amoxycillin and metronidazole and were managed expectantly. Hexoprenaline was administered if contractions occurred within the first 24 hours after admission to the trial. Outcome measures. The maternal outcome measures were clinical chorio-amnion itis and postpartum sepsis. The outcome measures for infants were perinatal death, RDS, mechanical ventilation, necrotising enterocolitis,and neonatal infection within 72 hours. Results. One hundred and two women who delivered 105 babies were randomised to the dexamethasone group and 102 women who delivered 103 babies, to the placebo group. The groups were well balanced with regard to clinical featur es. There was a trend towards fewer perinatal deaths in the dexamethasone g roup: 4 compared with 10 (P = 0.16, odds ratio 0.37, 95% confidence interva ls 0.09 - 1.34). A subanalysis of mothers who delivered more than 24 hours after admission to the study and their infants revealed a significant reduc tion in perinatal deaths; 1 death in the dexamethasone group and 7 in the p lacebo group, P = 0.047 (Fisher's exact test). No woman in either group dev eloped severe sepsis, and the incidence of sepsis in the women did not diff er significantly. Eleven infants in each group developed sepsis. 3Conclusion. This is the first randomised trial in women with PPROM. to com pare the effects of the use of corticosteroids with placebo, where all wome n received prophylactic antibiotics concomitantly with the corticosteroids. A trend towards an improved perinatal outcome was demonstrated in the wome n who received dexamethasone. There was no increased risk of infection in t he women or their infants where dexamethasone was administered. Administrat ion of corticosteroids to women with PPROM has more advantages than disadva ntages in developing countries.