Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

NCT ID: NCT01538875

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Hypertension, Pregnancy Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydralazine

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

Group Type: EXPERIMENTAL

Hydralazine

Intervention Type: DRUG

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).

Group Type: ACTIVE_COMPARATOR

Labetalol

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saint Thomas Hospital, Panama

OTHER

Sponsor Role: lead

Responsible Party

Osvaldo A. Reyes T.

Coordinator of Research and Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Countries

Panama

Other Identifiers

MHST2012-06

Identifier Type: -

Identifier Source: org_study_id