Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

Phase 3

Completed

• Conditions: Hypertension, Pregnancy Induced
• Interventions: Drug: Hydralazine; Drug: Labetalol

• Registration Number: NCT01538875
• Lead Sponsor: Saint Thomas Hospital, Panama

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 available

Study Timeline

• Study First Submitted: 2012-02-18
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-24
• Study Start: 2012-07
• Primary Completion: 2013-04
• Status Verified: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 261

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydralazine	Hydralazine	Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3).
Labetalol	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).

Primary Outcome Measures

Name	Time	Method
Control of Hypertensive Crisis	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.

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	10 months	Number of patients in each group that reported an adverse reaction to the drug assigned.
Number of doses	10 months	Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama