The effect of indomethacin tocolysis in preterm labour on perinatal outcome: a randomised placebo-controlled trial

Objective To determine whether indomethacin tocolysis in preterm labour is associated with a better perinatal outcome than placebo. Design A randomised placebo-controlled trial. Setting Two university teaching hospitals with level three neonatal intensi ve care units. Population Women in preterm labour with intact membranes between 23 and 30 weeks of gestation. Methods Random allocation to tocolysis with indomethacin (50 mg followed by 25 mg 6 hourly for 48 hours) or placebo in a double-blind fashion. Main outcome measures The primary outcome, perinatal mortality or severe ne onatal morbidity, was defined as perinatal death, necrotising enterocolitis , bronchopulmonary dysplasia, intraventricular haemorrhage or peri-ventricu lar leucomalacia. Data were analysed using odds ratios (OR) and 95% confide nce intervals (95% CI). Results Between March 1995 and February 1996, 34 women (39 babies) were rec ruited. The baseline characteristics of the two groups were similar. No pat ient was lost to follow up. In the indomethacin group, gestation was prolon ged by > 48 hours in 13/16 (81%) of women vs 10/18 (56%) in the placebo gro up. The incidence of perinatal mortality or severe neonatal morbidity was n ot significantly different between the groups, but occurred in twice as man y babies in the indomethacin group as in the placebo group-6/19 (32%) vs 3/ 20 (15%) OR (95% CI) 2.62 (0.44-18.8). There was one perinatal death, of a baby delivered at 24 weeks of gestation. This occurred in the indomethacin group. Conclusion There is no evidence that indomethacin tocolysis is beneficial, and further trials are needed to assess the impact of indomethacin tocolysi s in preterm labour.