Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 280 for:    Panama

Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

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.
 
ClinicalTrials.gov Identifier: NCT01538875
Recruitment Status : Completed
First Posted : February 24, 2012
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information
First Submitted Date  ICMJE February 18, 2012
First Posted Date  ICMJE February 24, 2012
Last Update Posted Date May 17, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2012)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01538875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2012)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension, Pregnancy Induced
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • Experimental: Hydralazine
    Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3).
    Intervention: Drug: Hydralazine
  • 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).
    Intervention: Drug: Labetalol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2013)
261
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2012)
284
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01538875
Other Study ID Numbers  ICMJE MHST2012-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor  ICMJE Saint Thomas Hospital, Panama
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Saint Thomas Hospital, Panama
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP