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JAMA. 2013 Jan 2;309(1):41-7. doi: 10.1001/jama.2012.153817.

Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial.

Author information

  • 1Department 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

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:

trialregister.nl Identifier: NTR1336.

PMID:
23280223
[PubMed - indexed for MEDLINE]
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