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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/21662

Title: Nifedipine versus atosiban for threatened preterm birth (APOSTEL III): a multicentre, randomised controlled trial
Authors: van Vliet, Elvira O. G.
Nijman, Tobias A. J.
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.
Jacquemyn, Yves
van Beek, Erik
Duvekot, Johannes J.
Franssen, Maureen T. M.
Papatsonis, Dimitri N.
Kok, Joke H.
van der Post, Joris A. M.
Franx, Arie
Mol, Ben Willem J.
Oudijk, Martijn A.
Issue Date: 2016
Citation: LANCET, 387 (10033), p. 2117-2124
Abstract: Background In women with threatened preterm birth, delay of delivery by 48 h allows antenatal corticosteroids to improve neonatal outcomes. For this reason, tocolytics are often administered for 48 h; however, there is no consensus about which drug results in the best maternal and neonatal outcomes. In the APOSTEL III trial we aimed to compare the effectiveness and safety of the calcium-channel blocker nifedipine and the oxytocin inhibitor atosiban in women with threatened preterm birth. Methods We did this multicentre, randomised controlled trial in ten tertiary and nine teaching hospitals in the Netherlands and Belgium. Women with threatened preterm birth (gestational age 25-34 weeks) were randomly assigned (1:1) to either oral nifedipine or intravenous atosiban for 48 h. An independent data manager used a web-based computerised programme to randomly assign women in permuted block sizes of four, with groups stratified by centre. Clinicians, outcome assessors, and women were not masked to treatment group. The primary outcome was a composite of adverse perinatal outcomes, which included perinatal mortality, bronchopulmonary dysplasia, sepsis, intraventricular haemorrhage, periventricular leukomalacia, and necrotising enterocolitis. Analysis was done in all women and babies with follow-up data. The study is registered at the Dutch Clinical Trial Registry, number NTR2947. Findings Between July 6, 2011, and July 7, 2014, we randomly assigned 254 women to nifedipine and 256 to atosiban. Primary outcome data were available for 248 women and 297 babies in the nifedipine group and 255 women and 294 babies in the atosiban group. The primary outcome occurred in 42 babies (14%) in the nifedipine group and in 45 (15%) in the atosiban group (relative risk [RR] 0.91, 95% CI 0.61-1.37). 16 (5%) babies died in the nifedipine group and seven (2%) died in the atosiban group (RR 2.20, 95% CI 0.91-5.33); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups. Interpretation In women with threatened preterm birth, 48 h of tocolysis with nifedipine or atosiban results in similar perinatal outcomes. Future clinical research should focus on large placebo-controlled trials, powered for perinatal outcomes.
Notes: [van Vliet, Elvira O. G.; Nijman, Tobias A. J.; Heida, Karst Y.; Bloemenkamp, Kitty W. M.; Franx, Arie; Oudijk, Martijn A.] Univ Med Ctr Utrecht, Dept Obstet, Wilhelmina Hosp, Birth Ctr,Div Woman & Baby, Utrecht, Netherlands. [Schuit, Ewoud] Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands. [Schuit, Ewoud] Stanford Univ, Stanford Prevent Res Ctr, Stanford, CA 94305 USA. [Opmeer, Brent C.] Univ Amsterdam, Acad Med Ctr, Clin Res Unit, Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands. [Kok, Marjolein; van der Post, Joris A. M.; Oudijk, Martijn A.] Univ Amsterdam, Acad Med Ctr, Dept Obstet & Gynecol, Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands. [Kok, Joke H.] Univ Amsterdam, Acad Med Ctr, Dept Neonatol, Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands. [Gyselaers, Wilfried] Ziekenhuis Oost Limburg, Dept Obstet & Gynecol, Genk, Belgium. [Gyselaers, Wilfried] Hasselt Univ, Dept Physiol, Diepenbeek, Belgium. [Porath, Martina M.] Maxima Med Ctr, Dept Obstet & Gynaecol, Veldhoven, Netherlands. [Woiski, Mallory] Univ Med Ctr Nijmegen, Dept Obstet & Gynaecol, Nijmegen, Netherlands. [Bax, Caroline J.] Vrije Univ Amsterdam, Med Ctr, Dept Obstet & Gynaecol, Amsterdam, Netherlands. [Bloemenkamp, Kitty W. M.] Leiden Univ, Med Ctr, Dept Obstet, Leiden, Netherlands. [Scheepers, Hubertina C. J.] Maastricht Univ, Med Ctr, Dept Obstet & Gynecol, NL-6200 MD Maastricht, Netherlands. [Jacquemyn, Yves] Univ Antwerp Hosp, Dept Gynecol & Obstet, Antwerp, Belgium. [van Beek, Erik] St Antonius Hosp, Dept Obstet & Gynaecol, Nieuwegein, Netherlands. [Duvekot, Johannes J.] Erasmus Univ, Med Ctr, Dept Obstet & Gynecol, Rotterdam, Netherlands. [Franssen, Maureen T. M.] Univ Groningen, Univ Med Ctr Groningen, Dept Obstet, Groningen, Netherlands. [Papatsonis, Dimitri N.] Amphia Hosp, Dept Obstet & Gynecol, Breda, Netherlands. [Mol, Ben W.] Univ Adelaide, Robinson Res Inst, Sch Paediat & Reprod Hlth, Adelaide, SA, Australia. [Mol, Ben W.] South Australian Hlth & Med Res Inst, Adelaide, SA, Australia.
URI: http://hdl.handle.net/1942/21662
DOI: 10.1016/S0140-6736(16)00548-1
ISI #: 000376450800035
ISSN: 0140-6736
Category: A1
Type: Journal Contribution
Validation: ecoom, 2017
Appears in Collections: Research publications

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