Nifedipine versus Fenoterol in the Management of Preterm Labor: A Randomized, Multicenter Clinical Study

Abstract

Purpose: To compare the efficacy of nifedipine and fenoterol in the management of threatened preterm labor (TPL). Methods: A randomized and multicenter study assessing the tocolytic effect of nifedipine versus fenoterol in patients admitted to the participating maternity units with a diagnosis of TPL and a cost-savings study for economic assessment. For a power of 80% and an α error equal to 0.05, 132 consecutive patients were recruited during the study period; 66 patients were assigned to each group. A χ² analysis and a mean differences test were performed according to variable types and survival curves per intention-to-treat. Results: Demographics were similar in both groups. The latency period was similar in both groups (26.7 vs. 25.6; p = 0.3). There were no differences in the results obtained. Nifedipine failed more frequently to obtain tocolysis when used as a first-line agent (80 vs. 90%, p = 0.0001). The group treated with fenoterol showed more drug adverse events (57.8 vs. 19.0%, p = 0.0001). The economic assessment did not evidence a significant difference in terms of cost savings between groups treated with either drug. Conclusion: The present study failed to demonstrate either clinical or economic superiority of any of the two drugs used in TPL management. The highest failure percentage of nifedipine when used as a first-line agent should encourage further research.

Effect of nifedipine and atosiban on perinatal brain injury: secondary analysis of the APOSTEL‐III trial

“…These results are supported by Salim et al . and Valdés et al . reporting lower incidence of Cesarean delivery in the group treated with nifedipine as compared with atosiban and betamimetics, respectively.…”

Cost-effectiveness of antenatal corticosteroids and tocolytic agents in the management of preterm birth: A systematic review

“… Newborn costs included in a retrospective cohort study Not specified Costs; adverse effects of terbutaline, pregnancy prolongation, maternal and neonatal morbidityd Not specified Maternal antepartum and neonatal period until discharged from hospital Low (9.5/22) Tomczyk 2015 54 Poland Tertiary hospital IV followed by continuous oral fenoterol vs IV for 48-72 hours only Women at risk of labour at 24-34 weeks gestation To compare cost and effectiveness of fenoterol therapy in pregnant women at risk of preterm labour in the hospital for two consecutive years: 2012, when fenoterol was widely used, and 2013, when restrictions were introduced. Cost analysis alongside a retrospective cohort study Not specified Cost of hospitalisation; mean week of delivery, mode of delivery, neonatal weight, delivery at term, APGARs, Hb and CRP after delivery, betamethasone and antibiotic administration Not specified Period of hospitalisation Low (10/22) Valdés 2012 53 Chile 3 Maternal-fetal units at tertiary hospitals Nifedipine (oral) vs Fenoterol (intravenous) Women at 22 to 34 weeks’ gestation in preterm labour Compare efficacy of nifedipine and fenoterol as a first-line tocolytic agent in the management of threatened preterm labor. Cost-minimisation analysis alongside randomised clinical trial 2007-08 Total costs; Outcomes from the RCT included: Clinical, metabolic, hemodynamic endpoints, the gestational age upon recruitment, effectiveness of the assigned tocolytic, latency period, adverse effects, the incidence of preterm delivery and perinatal outcomes.…”

Off-Label Drug Use in Pediatric Practice: Unsolved Problems

“…Так, в клиническом руководстве «Преждевременный раз-рыв плодных оболочек» специалистами ФГБУ «Научный центр акушерства, гинекологии и перинатологии имени академика В. И. Кулакова» в качестве препарата выбо-ра для проведения токолизиса рекомедован блокатор медленных кальциевых каналов нифедипин [3]. Однако, несмотря на большое количество проведенных клини-ческих исследований [4,5], в которых данный препарат по своей клинической эффективности и безопасности не уступал, а в некоторых случаях даже превосходил другие известные токолитики, в инструкции по медицин-скому применению нифедипина в качестве показаний указаны только стабильная стенокардия, стенокардия Принцметала и артериальная гипертензия.…”