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Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01538875
First received: February 18, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Control of Hypertensive Crisis [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Number of patients in each group that reported an adverse reaction to the drug assigned.

  • Number of doses [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538875

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

No publications provided

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
Study First Received: February 18, 2012
Last Updated: May 16, 2013
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Hypertension, pregnancy induced
Hydralazine
Labetalol

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

ClinicalTrials.gov processed this record on May 22, 2013