Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Magnesium Sulfate Labetalol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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..

Group Type ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type DRUG

intravenous infusion

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.

Group Type ACTIVE_COMPARATOR

Labetolol

Intervention Type DRUG

intravenous infusion

Interventions

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Magnesium sulfate

intravenous infusion

Intervention Type DRUG

Labetolol

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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(Trandate™,)

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No