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Completed

NCT Number: NCT04539379

Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate

the purpose of this study is to compare Intravenous infusion of Labetalol versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients using Transcranial Doppler

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine,Zagazig University

Zagazig, Zagazig, Elsharkia,egypt, 44519, Egypt

About this study

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 30 patients , (Group M) : will be given intravenous infusion of magnesium sulfate at a dose of 4 gm intravenously over 20 min as a loading dose then MgSO4 intravenous infusion is continued at a rate of 1 gm/h for 24 h or until obtain and stabilize the targeted blood pressure..

(Group L) : The patients will be given intravenous infusion of labetalol (Trandate™,) available in 20 ml ampoules containing 100mg labetalol (5mg/ml). Starting the infusion with 20mg/h and then titrate to obtain and stabilize the targeted blood pressure by adjusting the infusion as required every 15 - 30min to a maximum dose of 160mg/hr.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • acceptance
  • 21 to 45 years old.
  • mass index ≤ 35 kg/m2.
  • Singleton Pregnant female complicated with severe preeclampsia
  • Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg on two occasions at least 4 hours apart
  • Thrombocytopenia (platelet count less than 100,000 )
  • Impaired liver function indicated by elevated liver enzymes (to twice the upper limit normal concentration), and severe persistent right upper quadrant or epigastric pain not responding to medications and not explained by another diagnosis.
  • Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or doubling of the serum creatinine concentration in the absence of other renal disease)
  • Pulmonary edema
  • New-onset headache unresponsive to medications and not accounted for by alternative diagnoses
  • Visual disturbances.

Exclusion criteria

  • Preexisting heart disease
  • Known pulmonary disorders.
  • Inadequate temporal window.
  • Atrial fibrillation and any rhythm abnormality.
  • History of allergy or contraindications to either magnesium sulfate or labetolol.
  • Exposure to any of the study medications within 24 hours of enrollment.

Treatment and study plan

Magnesium sulfate

Drug

intravenous infusion

Labetolol

Drug

intravenous infusion

Other names: (Trandate™,)

Primary outcomes

  1. mean velocity

    Time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.

    mean velocity of middle cerebral artery

Secondary outcomes

  1. mean end diastolic velocity

    Time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.

    mean end diastolic velocity of middle cerebral artery

  2. pulsatility index

    Time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.

    pulsatility index of middle cerebral artery

  3. cerebral perfusion pressure

    Time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.

    cerebral perfusion pressure

  4. occurrence of seizures

    Time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.

    occurrence of seizures

  5. The need for other antihypertensive drugs

    Time frame: post-treatment one and six hours after drug administration.

    The need for other antihypertensive drugs (nifidibine, nitroglycerine, hydralazine, etc)

  6. adverse effects of the study drugs

    Time frame: post-treatment till 24 hours

    hypotension,Bradycardia,persistent hypertension

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2020
Registry last updated
Nov 15, 2022

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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