Comparison of intravenous labetalol and hydralazine for severe hypertension in pregnancy in Northeastern Nigeria: A randomized controlled trial.

Abstract

The objectives were to compare the efficacy and safety of intravenous hydralazine and labetalol for acutely lowering severe hypertension in pregnancy. This was a superiority parallel double-blinded randomized controlled trial conducted from October 2018 to June 2019 in two hospitals in Gombe, Nigeria. Pregnant women with a live singleton fetus at gestational age of at least 28weeks with severe hypertension were randomized (60 per group) to receive incremental doses of either intravenous labetalol (20mg; 40mg; 80mg; 80mg; and 80mg) or 10mg of intravenous hydralazine - up to a maximum of 5 doses - until the target blood pressure was achieved or the study was terminated. The main outcome measures were the mean reduction in mean arterial blood pressure and occurrence of persistent hypertension. Other endpoints were maternal side-effects, perinatal death, Apgar score at birth and SCBU admission. One hundred and thirteen patients' data were analyzed (fifty-six [56] in the hydralazine group and fifty-seven [57] in the labetalol group). There were no significant differences in the fall of the mean arterial blood pressure (labetalol; 24.19mmHg/hydralazine; 27.68mmHg) (p=0.192), maternal side effects, perinatal deaths, Apgar scores and SCBU admission between the two groups. Hydralazine, however, produced a more marked reduction in diastolic blood pressure than labetalol (p=0.012). Both labetalol and hydralazine are effective for acute blood pressure control in pregnancy with a similar safety profile. This study was self-funded and registered in the Pan African Clinical Trials Registry (www.pactr.orgPACTR202010738538062).