Comparing the effectiveness of two different dosage regimes of oral nifedipine in the treatment of preterm labour

Abstract

Objective: To compare the effectiveness and side effect of two different dosage regimes of oral Nifedipine in the treatment of preterm labour Methods: A double blinded randomized controlled trial in which 86 pregnant women with preterm labour were randomized to receive either the low or high dose regimen of Nifedipine for tocolysis. Low dose of 10 mg of oral Nifedipine then 5mg every 15min for 1hr 10mg 6hly for 48hrs, while the high dose was 20 mg of oral Nifedipine followed by 10 mg every 15 minutes for 1hr then 20mg 6hourly for 48 hours. The primary outcome was defined by mean uterine quiescence time and fetomaternal side effect were compared between the groups. Results: The mean uterine quiescence time for the low dose and high dose regime were comparable 13.60±11.69 hours versus 12.16±8.90 hours (P = 0.747) respectively, there was no statistical significance difference. None of the patients in both groups needed rescue treatment. Forty patients (93%) versus 41 patients (95%) (P = 0.506) of low and high dose respectively where able to achieve uterine quiescence within 48hours, there was no statistical significant difference. Maternal headache was higher in the high dose compared to the low dose but not statistically significant {19% vs 5% (p = 0.08)} None of the women in both groups had fetal heart rate abnormality. Discussion: The high dose regimen of oral Nifedipine for tocolysis does not have any advantage over the low dose regime in terms of effectiveness for tocolysis and infact low dose had a lower maternal side effect.