Nicorandil vs nifedipine for the treatment of preterm labour: a randomized clinical trial

ObjectiveTo compare the effectiveness of the potassium channel opener nicorandil with the calcium channel blocker nifedipine for tocolysis in preterm labour.MethodsA randomized clinical trial of 200 pregnant women in preterm labour was conducted at Menoufia University Hospital, Egypt. Eligible women were assigned at random into two groups: 100 women received nicorandil and 100 women received nifedipine. Prolongation of pregnancy for 48 h was the primary outcome measure. Maternal and neonatal outcomes were also assessed.ResultsNicorandil was comparable to nifedipine for prolongation of pregnancy for 48 h, 7 days and up to 37 weeks of gestation (p > 0.05). Women treated with nicorandil were significantly more likely to experience nausea and vomiting, maternal tachycardia and fetal tachycardia (60%, 55% and 30% of cases, respectively) compared with women treated with nifedipine (p < 0.001). Women treated with nifedipine were significantly more likely to experience palpitations (65%, p < 0.05) and headaches (70%, p < 0.001) than women treated with nicorandil. No differences in neonatal outcome were observed between the two groups (p > 0.05).ConclusionsNicorandil is as effective as nifedipine for tocolysis in preterm labour, but is more likely to cause maternal and fetal tachycardia which may be of concern. Larger studies are needed to assess the safety of nicorandil as a novel oral tocolytic agent.Clinical trial registration numberPan African Clinical Trials Registry (http://www.pactr.org). PACTR201405000757313.