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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01538875

Enrollment

261

Registered

2012-02-24

Start date

2012-07-31

Completion date

2013-05-31

Last updated

2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pregnancy Induced

Keywords

Hypertension, pregnancy induced, Hydralazine, Labetalol

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.

Interventions

DRUGHydralazine

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).

DRUGLabetalol

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
Control of Hypertensive Crisis	10 months	Number of patients with hypertensive crisis in which the blood pressure is controlled with the use of the assigned drug, without requiring additional medications.

Secondary

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

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026