Severe hypertension in pregnancy: hydralazine or labetalol. A randomized clinical trial.
Author(s): Vigil-De Gracia P, Lasso M, Ruiz E, Vega-Malek JC, de Mena FT, Lopez JC, or the HYLA treatment study
Affiliation(s): 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, Panama, Panama. firstname.lastname@example.org
Publication date & source: 2006-09, Eur J Obstet Gynecol Reprod Biol., 128(1-2):157-62. Epub 2006 Apr 18.
Publication type: Randomized Controlled Trial
OBJECTIVE: The objective was to compare the safety and efficacy of intravenous labetalol and intravenous hydralazine for acutely lowering blood pressure in pregnancy. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: This randomized clinical trial shows that labetalol and hydralazine fulfill the criteria required for an antihypertensive drug to treat severe hypertension in pregnancy.