Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

Hypertension, Pregnancy Induced Clinical Trial

Official title:

Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538875
• Other study ID #: MHST2012-06
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2012
• Last updated: May 16, 2013
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy Induced
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Pregnancy Complications

Intervention

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).
• 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).

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months	No
Secondary	Adverse reactions	Number of patients in each group that reported an adverse reaction to the drug assigned.	10 months	Yes
Secondary	Number of doses	Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.	10 months	No