Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

NCT01538875 | Completed Phase 3

• 1 other identifier: MHST2012-06
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertension, pregnancy induced; Hydralazine; Labetalol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Adverse reactions

  10 months

• Number of doses

  10 months

Study Arms (2)

Hydralazine

EXPERIMENTAL

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

Drug: Hydralazine

Labetalol

ACTIVE COMPARATOR

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).

Drug: Labetalol

Interventions

Hydralazine 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).

Hydralazine

Labetalol 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).

Labetalol

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age \> 24 weeks.
• Hypertensive Crisis (systolic pressure \> 160 mmHg / diastolic pressure \< 110mmHg).

You may not qualify if:

• Known allergy to hydralazine.
• Known allergy to labetalol.
• Severe Bradycardia

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Hydralazine; Labetalol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Research and Development

Study Record Dates

• First Submitted: February 18, 2012
• First Posted: February 24, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

PA (1)