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Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01538875
First Posted: February 24, 2012
Last Update Posted: May 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
  Purpose
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.

Condition Intervention Phase
Hypertension, Pregnancy Induced Drug: Hydralazine Drug: Labetalol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 261
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydralazine
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3).
Drug: Hydralazine
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes until high blood pressure is controlled (Maximum number of doses: 3).
Active Comparator: Labetalol
Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total).
Drug: Labetalol
Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total).

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age > 24 weeks.
  • Hypertensive Crisis (systolic pressure > 160 mmHg / diastolic pressure < 110mmHg).

Exclusion Criteria:

  • Known allergy to hydralazine.
  • Known allergy to labetalol.
  • Severe Bradycardia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538875


Locations
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
  More Information

Responsible Party: Osvaldo A. Reyes T., Coordinator of Research and Development, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01538875     History of Changes
Other Study ID Numbers: MHST2012-06
First Submitted: February 18, 2012
First Posted: February 24, 2012
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Hypertension, pregnancy induced
Hydralazine
Labetalol

Additional relevant MeSH terms:
Hypertension
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Hydralazine
Labetalol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists