Back to resultsHydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy
Primary Purpose
Hypertension, Pregnancy Induced
Status
Completed
Phase
Phase 3
Locations
Panama
Study Type
Interventional
Intervention
Hydralazine
Labetalol
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pregnancy Induced focused on measuring Hypertension, pregnancy induced, Hydralazine, Labetalol
Eligibility 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
Sites / Locations
- Saint Thomas Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydralazine
Labetalol
Arm Description
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3).
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).
Outcomes
Primary Outcome Measures
Control of Hypertensive Crisis
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
Number of patients in each group that reported an adverse reaction to the drug assigned.
Number of doses
Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.
Full Information
NCT ID
NCT01538875
First Posted
February 18, 2012
Last Updated
May 16, 2013
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT01538875
Brief Title
Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy
Official Title
Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pregnancy Induced
Keywords
Hypertension, pregnancy induced, Hydralazine, Labetalol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydralazine
Arm Type
Experimental
Arm Description
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3).
Arm Title
Labetalol
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Hydralazine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Labetalol
Intervention Description
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).
Primary Outcome Measure Information:
Title
Control of Hypertensive Crisis
Description
Number of patients with hypertensive crisis in which the blood pressure is controlled with the use of the assigned drug, without requiring additional medications.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
Number of patients in each group that reported an adverse reaction to the drug assigned.
Time Frame
10 months
Title
Number of doses
Description
Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.
Time Frame
10 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Saint Thomas Maternity Hospital
City
Panama
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy
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