The Effect of Nifedipine versus Magnesium Sulfate in preterm labor: A randomized clinical trial

Abstract

Aim: The aim of this study to evaluate the effect of Nifedipine versus Magnesium Sulfate in  preterm labor. Methods: 120 women with preterm labor between 24-37 week gestations were include in this study. Patients were selected randomly to receive either oral nifedipine  or intravenous magnesium sulfate. Nifedipine tocolysis was initiated with a 10 mg capsule which was repeated every 20 min (up to a maximal dose of 30 mg during the first hour of treatment) and then nifedipine maintenance dose was 10 mg every six hours. Tocolysis with magnesium sulfate was initiated with 10g (I.V) and then 5g (I.M) every 4 hours. Results: Total of 120 women were included ; 60 patients were randomly assigned to the nifedipine group and 60 were randomly assigned to the magnesium sulfate group. 3 patients   (5%)   after   24   hours,   5 patients (8.33%) after 48 hours, 4 patients (6.67%) after 72 hours and 33patients (55%) after 7 days had delivery in the nifedipine group and 6 patients (10%) after 24 hours, 3 patients (5%) after 48 hours, 3 patients (5%) after 72 hours and 37 patients (61.67%) after 7 days had delivery in the magnesium sulfate group. This characteristic was not statistically different between the two groups. In this study, 11 patients (23.33%) in nifedipine group and 9patient (15%) in magnesium sulfate group had a failure treatment (contractions did not subside) and needed to take other tocolytic medications. This characteristic was also not statistically different between the two groups.4 patients (6.67%) in the nifedipine group had severe hypotension and 2 patient (3.33%) in the magnesium sulphate group had severe flushing. These side effects caused drug discontinuation. Patients in the nifedipine group and magnesium sulfate group had the general side effects: 5 cases (8.33%) of headache and 2 case (3.33%) of flushing, respectively. All of obstetric characteristics were also not statistically different. Conclusion: We concluded that the oral nifedipine is a suitable alternative for magnesium sulfate with the same efficacy and side effects in the management of preterm labor.