Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Pregnancy Induced

Intervention / Treatment
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* Drug: Hydralazine
* Drug: Labetalol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydralazine<br>Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3). | Drug: Hydralazine<br>* 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).<br>|
| Active Comparator: Labetalol<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions | Number of patients in each group that reported an adverse reaction to the drug assigned. | 10 months | 
| Number of doses | Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, pregnancy induced, Hydralazine, Labetalol