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Title: Nifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial)
Authors: van Vliet, Elvira O. G.
Schuit, Ewoud
Heida, Karst Y.
Opmeer, Brent C.
Kok, Marjolein
GYSELAERS, Wilfried 
Porath, Martina M.
Woiski, Mallory
Bax, Caroline J.
Bloemenkamp, Kitty W. M.
Scheepers, Hubertina C. J.
Jaquemyn, Yves
van Beek, Erik
Duvekot, Hans J. J.
Franssen, Maureen T. M.
Bijvank, Bas N.
Kok, Joke H.
Franx, Arie
Mol, Ben Willem J.
Oudijk, Martijn A.
Issue Date: 2014
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 ≤ 10 mm or 2) a cervical length of 11-30 mm and a positive Fibronectin test or 3) ruptured membranes will be randomly allocated to treatment with nifedipine or atosiban. Primary outcome is a composite measure of severe neonatal morbidity and mortality. Secondary outcomes will be time to delivery, gestational age at delivery, days on ventilation support, neonatal intensive care (NICU) admittance, length admission in neonatal intensive care, total days in hospital until 3 months corrected age, convulsions, apnoea, asphyxia, proven meningitis, pneumothorax, maternal side effects and costs. Furthermore, an economic evaluation of the treatment will be performed. Analysis will be by intention to treat principle. The power calculation is based on an expected 10% difference in the prevalence of adverse neonatal outcome. This implies that 500 women have to be randomised (two sided test, β 0.2 at alpha 0.05).
Notes: van Vliet, EOG (reprint author), Univ Med Ctr Utrecht, Dept Obstet & Gynaecol, Utrecht, Netherlands.
Keywords: preterm birth; tocolytics; nifedipine; atosiban; outcome; drug safety
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e-ISSN: 1471-2393
DOI: 10.1186/1471-2393-14-93
ISI #: 000332668500001
Rights: © 2014 van Vliet et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Category: A1
Type: Journal Contribution
Validations: ecoom 2015
Appears in Collections:Research publications

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