Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

Saint Thomas Hospital (HST)

Status and phase: Completed; Phase 3

Conditions: Hypertension, Pregnancy Induced

Treatments: Drug: Labetalol; Drug: Hydralazine

Study type: Interventional

Funder types: Other

Identifiers

NCT01538875

MHST2012-06

Details and patient eligibility

About

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.

Enrollment: 261 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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261 participants in 2 patient groups

Hydralazine

Experimental group

Description:

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

Treatment:

Drug: Hydralazine

Labetalol

Active Comparator group

Description:

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).

Treatment:

Drug: Labetalol