TREASURE. Clinical practice evaluation of atosiban in preterm labour management in six European countries.

Objective To evaluate the efficacy and safety of early administration compared with standard administration of atosiban, when predefined eligibility criteria were met. Design A prospective, open-label, randomised clinical trial. Women were randomised to receive atosiban either immediately (early) or when specified criteria, in terms of duration/frequency of uterine contraction or status of cervical dilation/effacement, were fulfilled (standard). Setting Carried out at 105 centres in six European countries. Population Pregnant women admitted to hospital in threatened preterm labour between 24 and 34 weeks of gestation, comprising a subgroup of women enrolled in the Tractocile Efficacy Assessment Survey in Europe (TREASURE) clinical experience review. Main outcome measures Efficacy was defined as the successful delay of delivery with no alternative tocolytic agent for 48 hours. Results More women in the early group remained undelivered at 48 hours with no alternative tocolytic agent compared with those who received atosiban when specified criteria were fulfilled (88.9 versus 76.1%; P = 0.03). Safety was comparable between the groups. There were no statistical differences in maternal, fetal or neonatal adverse events between the early and standard atosiban arms. Conclusions The use of atosiban was effective for the delay of preterm labour and presented no safety concerns irrespective of the time it was administered.