• Eur. J. Obstet. Gynecol. Reprod. Biol. · Sep 2006

    Randomized Controlled Trial

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

    • Paulino Vigil-De Gracia, Martin Lasso, Esteban Ruiz, Juan Carlos Vega-Malek, Flor Tem de Mena, Juan Carlos López, and or the HYLA treatment study.
    • The Obstetric Intensive Unit, Department of Gynecology and Obstetrics, Complejo Hospitalario "Arnulfo Arias Madrid" Caja de Seguro Social, Apartado Postal 87 32 24, Zona 7, Panamá, Panama. pvigil-d@cwp.net.pa
    • Eur. J. Obstet. Gynecol. Reprod. Biol. 2006 Sep 1; 128 (1-2): 157-62.

    ObjectiveThe objective was to compare the safety and efficacy of intravenous labetalol and intravenous hydralazine for acutely lowering blood pressure in pregnancy.Study DesignTwo 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.ResultsWomen 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.ConclusionsThis randomized clinical trial shows that labetalol and hydralazine fulfill the criteria required for an antihypertensive drug to treat severe hypertension in pregnancy.

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