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Type: Journal article
Title: Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial
Author: Roos, C.
Spaanderman, M.
Schuit, E.
Bloemenkamp, K.
Bolte, A.
Cornette, J.
Duvekot, J.
van Eyck, J.
Franssen, M.
de Groot, C.
Kok, J.
Kwee, A.
Merien, A.
Bijivank, B.
Opmeer, B.
Oudijk, M.
van Pampus, M.
Papatsonis, D.
Porath, M.
Scheepers, H.
et al.
Citation: JAMA: Journal of the American Medical Association, 2013; 309(1):41-47
Publisher: American Medical Association
Issue Date: 2013
ISSN: 0098-7484
Statement of
Carolien Roos ... Ben Willem J. Mol ... et al. for the APOSTEL-II Study Group
Abstract: IMPORTANCE In threatened preterm labor, maintenance tocolysis with nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, may improve perinatal outcome. OBJECTIVE To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth. DESIGN, SETTING, AND PARTICIPANTS APOSTEL-II (Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor) is a double-blind, placebo-controlled trial performed in 11 perinatal units including all tertiary centers in the Netherlands. From June 2008 to February 2010, women with threatened preterm labor between 26 weeks (plus 0 days) and 32 weeks (plus 2 days) gestation, who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids, were enrolled. Surviving infants were followed up until 6 months after birth (ended August 2010). INTERVENTION Randomization assigned 406 women to maintenance tocolysis with nifedipine orally (80 mg/d; n = 201) or placebo (n = 205) for 12 days. Assigned treatment was masked from investigators, participants, clinicians, and research nurses. MAIN OUTCOME MEASURES Primary outcome was a composite of adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage >grade 2, periventricular leukomalacia >grade 1, or necrotizing enterocolitis). Analyses were completed on an intention-to-treat basis. RESULTS Mean (SD) gestational age at randomization was 29.2 (1.7) weeks for both groups. Adverse perinatal outcome was not significantly different between groups: 11.9% (24/201; 95% CI, 7.5%-16.4%) for nifedipine vs 13.7% (28/205; 95% CI, 9.0%-18.4%) for placebo (relative risk, 0.87; 95% CI, 0.53-1.45). CONCLUSIONS AND RELEVANCE In patients with threatened preterm labor, nifedipine-maintained tocolysis did not result in a statistically significant reduction in adverse perinatal outcomes when compared with placebo. Although the lower than anticipated rate of adverse perinatal outcomes in the control group indicates that a benefit of nifedipine cannot completely be excluded, its use for maintenance tocolysis does not appear beneficial at this time. TRIAL REGISTRATION Identifier: NTR1336.
Keywords: APOSTEL-II Study Group
Enterocolitis, Necrotizing
Lung Diseases
Intracranial Hemorrhages
Leukomalacia, Periventricular
Fetal Death
Infant, Newborn, Diseases
Tocolytic Agents
Drug Administration Schedule
Double-Blind Method
Infant, Newborn
Obstetric Labor, Premature
Young Adult
Rights: ©2013 American Medical Association. All rights reserved.
DOI: 10.1001/jama.2012.153817
Published version:
Appears in Collections:Aurora harvest 7
Paediatrics publications

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