Objectives: To assess the efficacy and safety of nicardipine in comparison to labetalol in the initial management of severe hypertension in pregnancy. DESIGN. Randomized prospective study.
Setting: The obstetric ward of the teaching hospital of Monastir Tunisia.
Patients: Sixty consecutive pregnant women admitted beyond the 24th week of pregnancy with severe hypertension.
Intervention: Patients were randomly assigned to receive intravenously for 1 h either labetalol ( n=30) or nicardipine ( n=30). Treatment was titrated to achieve a 20% lowering of blood pressure (BP).
Measurements: Maternal BP and heart rate were measured at inclusion and repeatedly during the first hour following the drugs administration. Fetal heart rate was recorded throughout the study period. The main outcome endpoints were the success rate and the length of time needed to achieve the therapeutic goal. The rate of maternal and fetal adverse events and dose adjustments were also analyzed.
Results: Labetalol and nicardipine achieved the 20% lowering in BP in the same proportion (63% and 70% success rates, respectively). Overall nicardipine caused a significantly greater decrease in systolic and diastolic BP. No patient had any episode of hypotension. The length of time to achieve the BP goal was also similar (12 vs. 11 min, respectively). Both drugs were well tolerated except for a moderate tachycardia observed with the use of nicardipine.
Conclusion: Nicardipine and labetalol are effective and safe in the initial treatment of severe hypertension of pregnancy.