Tags

Type your tag names separated by a space and hit enter

Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial.
JAMA. 2013 Jan 02; 309(1):41-7.JAMA

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.

Authors+Show Affiliations

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.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23280223

Citation

Roos, Carolien, et al. "Effect of Maintenance Tocolysis With Nifedipine in Threatened Preterm Labor On Perinatal Outcomes: a Randomized Controlled Trial." JAMA, vol. 309, no. 1, 2013, pp. 41-7.
Roos C, Spaanderman ME, Schuit E, et al. Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial. JAMA. 2013;309(1):41-7.
Roos, C., Spaanderman, M. E., Schuit, E., Bloemenkamp, K. W., Bolte, A. C., Cornette, J., Duvekot, J. J., van Eyck, J., Franssen, M. T., de Groot, C. J., Kok, J. H., Kwee, A., Merién, A., Nij Bijvank, B., Opmeer, B. C., Oudijk, M. A., van Pampus, M. G., Papatsonis, D. N., Porath, M. M., ... Lotgering, F. K. (2013). Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: a randomized controlled trial. JAMA, 309(1), 41-7. https://doi.org/10.1001/jama.2012.153817
Roos C, et al. Effect of Maintenance Tocolysis With Nifedipine in Threatened Preterm Labor On Perinatal Outcomes: a Randomized Controlled Trial. JAMA. 2013 Jan 2;309(1):41-7. PubMed PMID: 23280223.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of maintenance tocolysis with nifedipine in threatened preterm labor on perinatal outcomes: 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 - Nij Bijvank,Bas, 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, AU - ,, PY - 2013/1/3/entrez PY - 2013/1/3/pubmed PY - 2013/1/4/medline SP - 41 EP - 7 JF - JAMA JO - JAMA VL - 309 IS - 1 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/23280223/Effect_of_maintenance_tocolysis_with_nifedipine_in_threatened_preterm_labor_on_perinatal_outcomes:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2012.153817 DB - PRIME DP - Unbound Medicine ER -