Document Detail


Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial.
MedLine Citation:
PMID:  23280223     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
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: trialregister.nl Identifier: NTR1336.
Authors:
Carolien Roos; Marc E A Spaanderman; Ewoud Schuit; Kitty W M Bloemenkamp; Antoinette C Bolte; Jérôme Cornette; Johannes J J Duvekot; Jim van Eyck; Maureen T M Franssen; Christianne J de Groot; Joke H Kok; Anneke Kwee; Ashley Merién; Bas Nij Bijvank; Brent C Opmeer; Martijn A Oudijk; Mariëlle G van Pampus; Dimitri N M Papatsonis; Martina M Porath; Hubertina C J Scheepers; Sicco A Scherjon; Krystyna M Sollie; Sylvia M C Vijgen; Christine Willekes; Ben Willem J Mol; Joris A M van der Post; Fred K Lotgering;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA : the journal of the American Medical Association     Volume:  309     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-02     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  41-7     Citation Subset:  AIM; IM    
Affiliation:
Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre, Local Postal Code 791, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. c.roos@obgyn.umcn.nl
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