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Completed

NCT Number: NCT01538875

Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

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.

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Key information

Conditions

Hypertension, Pregnancy Induced Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. Control of Hypertensive Crisis

    Time frame: 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 outcomes

  1. Adverse reactions

    Time frame: 10 months

    Number of patients in each group that reported an adverse reaction to the drug assigned.

  2. Number of doses

    Time frame: 10 months

    Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2012
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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