Clinical Trial: Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.

Brief Summary: Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure > 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. The management in this population had been studied, but no consensus has been reached with regards to which treatment is better. Our study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.

Detailed Summary:
Sponsor: Saint Thomas Hospital, Panama

Current Primary Outcome: Control of Hypertensive Crisis [ Time Frame: 10 months ]

Number of patients with hypertensive crisis in which the blood pressure is controlled with the use of the assigned drug, without requiring additional medications.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse reactions [ Time Frame: 10 months ]
    Number of patients in each group that reported an adverse reaction to the drug assigned.
  • Number of doses [ Time Frame: 10 months ]
    Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.


Original Secondary Outcome: Same as current

Information By: Saint Thomas Hospital, Panama

Dates:
Date Received: February 18, 2012
Date Started: July 2012
Date Completion:
Last Updated: May 16, 2013
Last Verified: May 2013