Maintenance nifedipine tocolysis compared with placebo: A randomized controlled trial

Deirdre J. Lyell, Kristin M. Pullen, Jana Mannan, Usha Chitkara, Maurice L. Druzin, Aaron Caughey, Yasser Y. El-Sayed

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

OBJECTIVE:: To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes. METHODS:: A prospective, randomized double-blind, multicenter study was conducted. After successful tocolysis, patients were randomly assigned to receive 20 mg nifedipine or an identical-appearing placebo every 4-6 hours until 37 weeks of gestation. The primary outcome was attainment of 37 weeks of gestation. Patients were enrolled between 24 weeks and 34 weeks if they had six or fewer contractions per hour, intact membranes, and less than 4 cm cervical dilation. Exclusion criteria were placental abruption or previa, fetal anomaly incompatible with life, or maternal medical contraindication to tocolysis. Sixty-six patients were required for 80% power to detect a 50% reduction in birth before 37 weeks, with a two-tailed alpha of 0.05. Data were analyzed by intent to treat. RESULTS:: Seventy-one patients were randomly assigned. Two patients were excluded after randomization and one was lost to follow-up. Thirty-five patients received placebo, and 33 received nifedipine. There were no maternal demographic differences between groups; the placebo group was significantly more dilated and effaced at study entry. There was no difference in attainment of 37 weeks (39% nifedipine compared with 37% placebo, P>.91), mean delay of delivery (33.5±19.9 days nifedipine compared with 32.6±21.4 days placebo, P=.81) or delay of delivery for greater than 48 hours or 1, 2, 3, or 4 weeks. Neonatal outcomes were similar between groups. CONCLUSION:: When compared with placebo, maintenance nifedipine tocolysis did not confer a large reduction in preterm birth or improvement in neonatal outcomes.

Original languageEnglish (US)
Pages (from-to)1221-1226
Number of pages6
JournalObstetrics and Gynecology
Volume112
Issue number6
DOIs
StatePublished - Dec 2008
Externally publishedYes

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Tocolysis
Nifedipine
Randomized Controlled Trials
Placebos
Maintenance
Pregnancy
Mothers
Abruptio Placentae
Premature Obstetric Labor
Lost to Follow-Up
Premature Birth
Random Allocation
Double-Blind Method
Multicenter Studies
Dilatation
Demography
Parturition
Membranes

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

Lyell, D. J., Pullen, K. M., Mannan, J., Chitkara, U., Druzin, M. L., Caughey, A., & El-Sayed, Y. Y. (2008). Maintenance nifedipine tocolysis compared with placebo: A randomized controlled trial. Obstetrics and Gynecology, 112(6), 1221-1226. https://doi.org/10.1097/AOG.0b013e31818d8386

Maintenance nifedipine tocolysis compared with placebo : A randomized controlled trial. / Lyell, Deirdre J.; Pullen, Kristin M.; Mannan, Jana; Chitkara, Usha; Druzin, Maurice L.; Caughey, Aaron; El-Sayed, Yasser Y.

In: Obstetrics and Gynecology, Vol. 112, No. 6, 12.2008, p. 1221-1226.

Research output: Contribution to journalArticle

Lyell, DJ, Pullen, KM, Mannan, J, Chitkara, U, Druzin, ML, Caughey, A & El-Sayed, YY 2008, 'Maintenance nifedipine tocolysis compared with placebo: A randomized controlled trial', Obstetrics and Gynecology, vol. 112, no. 6, pp. 1221-1226. https://doi.org/10.1097/AOG.0b013e31818d8386
Lyell, Deirdre J. ; Pullen, Kristin M. ; Mannan, Jana ; Chitkara, Usha ; Druzin, Maurice L. ; Caughey, Aaron ; El-Sayed, Yasser Y. / Maintenance nifedipine tocolysis compared with placebo : A randomized controlled trial. In: Obstetrics and Gynecology. 2008 ; Vol. 112, No. 6. pp. 1221-1226.
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T2 - A randomized controlled trial

AU - Lyell, Deirdre J.

AU - Pullen, Kristin M.

AU - Mannan, Jana

AU - Chitkara, Usha

AU - Druzin, Maurice L.

AU - Caughey, Aaron

AU - El-Sayed, Yasser Y.

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N2 - OBJECTIVE:: To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes. METHODS:: A prospective, randomized double-blind, multicenter study was conducted. After successful tocolysis, patients were randomly assigned to receive 20 mg nifedipine or an identical-appearing placebo every 4-6 hours until 37 weeks of gestation. The primary outcome was attainment of 37 weeks of gestation. Patients were enrolled between 24 weeks and 34 weeks if they had six or fewer contractions per hour, intact membranes, and less than 4 cm cervical dilation. Exclusion criteria were placental abruption or previa, fetal anomaly incompatible with life, or maternal medical contraindication to tocolysis. Sixty-six patients were required for 80% power to detect a 50% reduction in birth before 37 weeks, with a two-tailed alpha of 0.05. Data were analyzed by intent to treat. RESULTS:: Seventy-one patients were randomly assigned. Two patients were excluded after randomization and one was lost to follow-up. Thirty-five patients received placebo, and 33 received nifedipine. There were no maternal demographic differences between groups; the placebo group was significantly more dilated and effaced at study entry. There was no difference in attainment of 37 weeks (39% nifedipine compared with 37% placebo, P>.91), mean delay of delivery (33.5±19.9 days nifedipine compared with 32.6±21.4 days placebo, P=.81) or delay of delivery for greater than 48 hours or 1, 2, 3, or 4 weeks. Neonatal outcomes were similar between groups. CONCLUSION:: When compared with placebo, maintenance nifedipine tocolysis did not confer a large reduction in preterm birth or improvement in neonatal outcomes.

AB - OBJECTIVE:: To estimate whether maintenance nifedipine tocolysis after arrested preterm labor prolongs pregnancy and improves neonatal outcomes. METHODS:: A prospective, randomized double-blind, multicenter study was conducted. After successful tocolysis, patients were randomly assigned to receive 20 mg nifedipine or an identical-appearing placebo every 4-6 hours until 37 weeks of gestation. The primary outcome was attainment of 37 weeks of gestation. Patients were enrolled between 24 weeks and 34 weeks if they had six or fewer contractions per hour, intact membranes, and less than 4 cm cervical dilation. Exclusion criteria were placental abruption or previa, fetal anomaly incompatible with life, or maternal medical contraindication to tocolysis. Sixty-six patients were required for 80% power to detect a 50% reduction in birth before 37 weeks, with a two-tailed alpha of 0.05. Data were analyzed by intent to treat. RESULTS:: Seventy-one patients were randomly assigned. Two patients were excluded after randomization and one was lost to follow-up. Thirty-five patients received placebo, and 33 received nifedipine. There were no maternal demographic differences between groups; the placebo group was significantly more dilated and effaced at study entry. There was no difference in attainment of 37 weeks (39% nifedipine compared with 37% placebo, P>.91), mean delay of delivery (33.5±19.9 days nifedipine compared with 32.6±21.4 days placebo, P=.81) or delay of delivery for greater than 48 hours or 1, 2, 3, or 4 weeks. Neonatal outcomes were similar between groups. CONCLUSION:: When compared with placebo, maintenance nifedipine tocolysis did not confer a large reduction in preterm birth or improvement in neonatal outcomes.

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