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

Roos C1, Spaanderman ME, Schuit E, Bloemenkamp KW, Bolte AC, Cornette J, Duvekot JJ, van Eyck J, Franssen MT, de Groot CJ, Kok JH, Kwee A, Merién A, Nij Bijvank B, Opmeer BC, Oudijk MA, van Pampus MG, Papatsonis DN, Porath MM, Scheepers HC, Scherjon SA, S

JAMA, 2013, 2;309(1), pages 41-7

Editor’s comment: Prof. Jim Thornton: Maintenance tocolysis with nifedipine is ineffective
Among women in preterm labour who remained undelivered after 48 hours of initial tocolysis while steroids were administered, further maintenance tocolysis with nifedipine neither delayed delivery, nor reduced any other important adverse perinatal outcomes.

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.

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Commentaries by Editor Prof. Jim Thornton