NCT01538875

Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Saint Thomas Hospital, Panama · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Pregnancy Induced

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2012-02-24
• Last updated: 2013-05-17

Locations

1 site across 1 country: Panama