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Severe hypertension in pregnancy: hydralazine or labetalol. A randomized clinical trial.

Research paper by Paulino P Vigil-De Gracia, Martin M Lasso, Esteban E Ruiz, Juan Carlos JC Vega-Malek, Flor Tem FT de Mena, Juan Carlos JC López,

Indexed on: 20 Apr '06Published on: 20 Apr '06Published in: European Journal of Obstetrics & Gynecology and Reproductive Biology



Abstract

The objective was to compare the safety and efficacy of intravenous labetalol and intravenous hydralazine for acutely lowering blood pressure in pregnancy.Two hundred women with severe hypertension in pregnancy were randomized to receive hydralazine (5 mg as a slow bolus dose given intravenously, and repeated every 20 min up to a maximum of five doses) or labetalol (20-mg intravenous bolus dose followed by 40 mg if not effective within 20 min, followed by 80 mg every 20 min up to a maximum dose of 300 mg). The primary end point was successful lowering of blood pressure and maternal hypotension.Women were similar with respect to characteristics at randomization. No significant differences were observed for maternal hypotension or persistent severe hypertension; only two patients in the hydralazine group presented with hypotension. Palpitations (p=0.01) and maternal tachycardia (p=0.05) occurred significantly more often in patients treated with hydralazine. The main neonatal outcomes were very similar per group; however, hypotension and bradycardia were significantly more frequent in the labetalol group. There were two neonatal deaths per antihypertensive drug group.This randomized clinical trial shows that labetalol and hydralazine fulfill the criteria required for an antihypertensive drug to treat severe hypertension in pregnancy.