Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial)

Elvira OG van Vliet, Ewoud Schuit, Karst Y Heida, Brent C Opmeer, Marjolein Kok, Wilfried Gyselaers, Martina M Porath, Mallory Woiski, Caroline J Bax, Kitty WM Bloemenkamp, Hubertina CJ Scheepers, Yves Jaquemyn, Erik van Beek, Hans JJ Duvekot, Maureen TM Franssen, Bas N Bijvank, Joke H Kok, Arie Franx, Ben Willem J Mol, Martijn A Oudijk

Preterm birth is the most common cause of neonatal morbidity and mortality. Postponing delivery for 48 hours with tocolytics to allow for maternal steroid administration and antenatal transportation to a centre with neonatal intensive care unit facilities is the standard treatment for women with threatening preterm delivery in most centres. However, there is controversy as to which tocolytic agent is the drug of first choice. Previous trials have focused on tocolytic efficacy and side effects, and are probably underpowered to detect clinically meaningfull differences in neonatal outcome. Thus, the current evidence is inconclusive to support a balanced recommendation for clinical practice. This multicenter randomised clinical trial aims to compare nifedipine and atosiban in terms of neonatal outcome, duration of pregnancy and maternal side effects.