Abstract
This is a prospective controlled randomized trial conducted in 92 women with singleton pregnancies in preterm labor. The tocolytic efficacy and safety of combination atosiban and nifedipine was compared with that of the single agent, atosiban. Both lines of intervention was administered for 48 hours. Progression of labor was assessed by the frequency of uterine contractions and cervical changes. For statistical purpose, intent-to-treat (ITT) analysis was used throughout. Efficacy, as determined by the proportion of women in each group who did not deliver after therapy initiation, was comparable with no significant differences, at 48 hrs (91.5% vs. 91.1%) and at 7 days (90.7% vs. 85.7%) for the atosiban and the combination groups respectively. Safety was assessed by the numbers of adverse events. Maternal side effects were reported more in the combination group (34% vs. 64%; P = 0.006). Perinatal outcomes were similar between the groups. We conclude that the addition of nifedipine did not substantially improve the clinical outcomes beyond that were achieved with atosiban alone. Moreover, it has increased maternal side effects. Future research could focus on combination of other tocolytics.
Highlights
Preterm birth, defined as birth at less than 37 + 0 weeks of gestation, accounts for 5% to 11% of births in the world [1]
Meta analysis from Cochrane systematic review failed to demonstrate the superiority of atosiban over betamimetics or placebo in terms of tocolytic efficacy or infant outcomes, but, the maternal drug reactions were fewer with atosiban [5]
This study explores the clinical utility of combining two tocolytic agents for the treatment of preterm labor (PTL)
Summary
Preterm birth, defined as birth at less than 37 + 0 weeks of gestation, accounts for 5% to 11% of births in the world [1]. It represents the single largest cause of mortality and morbidity for newborns and a major cause of morbidity for pregnant women [2]. Meta analysis from Cochrane systematic review failed to demonstrate the superiority of atosiban over betamimetics or placebo in terms of tocolytic efficacy or infant outcomes, but, the maternal drug reactions were fewer with atosiban [5]. Nifedipine is the only agent associated with improved perinatal outcomes and fewer maternal side-effects than betamimetics [6]. Atosiban and nifedipine have been shown to have equal efficacy, maternal side-effects were more pronounced with nifedipine [7,8]
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