TY - JOUR
T1 - Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes
T2 - A randomized controlled trial
AU - Roos, Carolien
AU - Spaanderman, Marc E.A.
AU - Schuit, Ewoud
AU - Bloemenkamp, Kitty W.M.
AU - Bolte, Antoinette C.
AU - Cornette, Jérôme
AU - Duvekot, Johannes J.J.
AU - Van Eyck, Jim
AU - Franssen, Maureen T.M.
AU - De Groot, Christianne J.
AU - Kok, Joke H.
AU - Kwee, Anneke
AU - Merién, Ashley
AU - Bijvank, Bas Nij
AU - Opmeer, Brent C.
AU - Oudijk, Martijn A.
AU - Van Pampus, Mariëlle G.
AU - Papatsonis, Dimitri N.M.
AU - Porath, Martina M.
AU - Scheepers, Hubertina C.J.
AU - Scherjon, Sicco A.
AU - Sollie, Krystyna M.
AU - Vijgen, Sylvia M.C.
AU - Willekes, Christine
AU - Mol, Ben Willem J.
AU - Van Der Post, Joris A.M.
AU - Lotgering, Fred K.
PY - 2013/1/2
Y1 - 2013/1/2
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/84871763412
U2 - 10.1001/jama.2012.153817
DO - 10.1001/jama.2012.153817
M3 - Article
C2 - 23280223
AN - SCOPUS:84871763412
SN - 0098-7484
VL - 309
SP - 41
EP - 47
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 1
ER -