Nicardipine versus salbutamol in the treatment of premature labor. A prospective randomized study.

OBJECTIVE: To compare the tocolytic action and the side effects of nicardipine to those of salbutamol in patients presenting premature labor in order to propose nicardipine as a promising alternative to salbutamol in the treatment of premature labor. STUDY DESIGN: Ninety patients admitted to the Saint-Antoine Hospital (Paris, France) for premature labor were included in this prospective randomized open study comparing nicardipine and salbutamol. Each study group included 45 patients. RESULTS: The mean term of delivery in the nicardipine group was 38.4 +/- 1.7 and 37.6 +/- 2.1 weeks in the salbutamol group (P < 0.05). The percentage of deliveries after 37 gestational weeks was higher with nicardipine (P < 0.05). The birthweight of infants was 3131 +/- 488 g with patients treated with nicardipine and 3019 +/- 494 g with the salbutamol group (NS). The Apgar scores were identical in the two groups at 1 and 5 min. There was no statistically significant difference in the number of neonates admitted into intensive care nor the premature infant center between the two groups. Nicardipine reduced the systolic and diastolic blood pressure whereas there was no change in the salbutamol group. Maternal pulse rate was significantly increased in the salbutamol group (P < 0.01) and was unchanged in the nicardipine group. The most common side-effects with nicardipine were headaches, and with salbutamol, tremors and palpitations. CONCLUSIONS: Nicardipine is a tocolytic agent as effective as salbutamol in the treatment of premature labor. The use of nicardipine is an interesting alternative to salbutamol, especially in cases of hypertension, diabetes or maternal cardiopathy.