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

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

*Corresponding author for this work

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    Abstract

    Background: 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.

    Methods/Design: The Apostel III trial is a nationwide multicenter randomised controlled study. Women with threatened preterm labour (gestational age 25-34 weeks) defined as at least 3 contractions per 30 minutes, and 1) a cervical length of

    Discussion: This trial will provide evidence on the optimal drug of choice in acute tocolysis in threatening preterm labour.

    Original languageEnglish
    Article number93
    Number of pages6
    JournalBMC Pregnancy and Childbirth
    Volume14
    DOIs
    Publication statusPublished - 3-Mar-2014

    Keywords

    • Preterm birth
    • Tocolytics
    • Nifedipine
    • Atosiban
    • Outcome
    • Drug safety
    • BIRTH
    • DELIVERY
    • EPIDEMIOLOGY
    • METAANALYSIS
    • THERAPY

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