Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy
Information source: Saint Thomas Hospital, Panama
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension, Pregnancy Induced
Intervention: Hydralazine (Drug); Labetalol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Saint Thomas Hospital, Panama
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.
Clinical Details
Official title: Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Control of Hypertensive Crisis
Secondary outcome: Adverse reactionsNumber of doses
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Saint Thomas Maternity Hospital, Panama, Panama
Additional Information
Starting date: July 2012
Last updated: May 16, 2013
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