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

Eur J Obstet Gynecol Reprod Biol. 2006 Sep-Oct;128(1-2):157-62. doi: 10.1016/j.ejogrb.2006.02.015. Epub 2006 Apr 18.

Abstract

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adrenergic Antagonists / administration & dosage
  • Adrenergic Antagonists / therapeutic use*
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / therapeutic use*
  • Female
  • Humans
  • Hydralazine / administration & dosage
  • Hydralazine / therapeutic use*
  • Hypertension / drug therapy*
  • Hypotension / chemically induced
  • Labetalol / administration & dosage
  • Labetalol / therapeutic use*
  • Pre-Eclampsia / prevention & control
  • Pregnancy
  • Pregnancy Outcome
  • Tachycardia / chemically induced
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / therapeutic use*

Substances

  • Adrenergic Antagonists
  • Antihypertensive Agents
  • Vasodilator Agents
  • Hydralazine
  • Labetalol