- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04539379
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zagazig, Elsharkia,egypt
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Zagazig, Zagazig, Elsharkia,egypt, Egypt, 44519
- Faculty of Medicine,Zagazig University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: magnesium sulfate
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..
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intravenous infusion
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Active Comparator: labetolol
The patients will be given intravenous infusion of labetolol (Trandate™, 5mg/ml) 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.
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intravenous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean velocity
Time Frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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mean velocity of middle cerebral artery
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basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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mean end diastolic velocity of middle cerebral artery
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basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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pulsatility index
Time Frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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pulsatility index of middle cerebral artery
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basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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cerebral perfusion pressure
Time Frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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cerebral perfusion pressure
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basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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occurrence of seizures
Time Frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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occurrence of seizures
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basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
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The need for other antihypertensive drugs
Time Frame: post-treatment one and six hours after drug administration.
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The need for other antihypertensive drugs (nifidibine, nitroglycerine, hydralazine, etc)
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post-treatment one and six hours after drug administration.
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adverse effects of the study drugs
Time Frame: post-treatment till 24 hours
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hypotension,Bradycardia,persistent hypertension
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post-treatment till 24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Howida A kamal, M.D, zagazig U
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pregnancy Complications
- Hypertension, Pregnancy-Induced
- Pre-Eclampsia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- 6353 (FDA Office of Orphan Products Development (OOPD))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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