Effects of tocolysis with nifedipine or atosiban on child outcome: follow up of the APOSTEL III trial

OBJECTIVE: Compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years. DESIGN: The APOSTEL III trial was a multicentre RCT that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group. METHODS: Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems, and general health. MAIN OUTCOME MEASURES: Main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years. RESULTS: Of the 426 women eligible for follow up, 196 (46%) parents returned the questionnaires of 115 children in the nifedipine and 110 children in the atosiban group. Abnormal development occurred in 32 children (30%) in the nifedipine group and 38 children (38%) in the atosiban group (OR 0.74, 95% CI 0.41-1.34). The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups. Sensitivity analysis including all children of the APOSTEL III trial including a comparison of deceased children resulted in a higher rate of healthy survival in the nifedipine group (64% versus 54%), but no significant difference in overall mortality (5.4% versus 2.7%). There were no significant subgroup effects. CONCLUSION: Outcomes on broad child neurodevelopment, executive function, behaviour and general health were comparable in both groups. Neither nifedipine nor atosiban can be considered as the preferred treatment for women with threatened preterm birth.