Magnesium Sulfate Clinical Trial
Official title:
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler
NCT number | NCT04539379 |
Other study ID # | 6353 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | March 1, 2022 |
Verified date | November 2022 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | March 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine,Zagazig University | Zagazig | Zagazig, Elsharkia,egypt |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean velocity | mean velocity of middle cerebral artery | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | |
Secondary | mean end diastolic velocity | mean end diastolic velocity of middle cerebral artery | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | |
Secondary | pulsatility index | pulsatility index of middle cerebral artery | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | |
Secondary | cerebral perfusion pressure | cerebral perfusion pressure | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | |
Secondary | occurrence of seizures | occurrence of seizures | basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration. | |
Secondary | The need for other antihypertensive drugs | The need for other antihypertensive drugs (nifidibine, nitroglycerine, hydralazine, etc) | post-treatment one and six hours after drug administration. | |
Secondary | adverse effects of the study drugs | hypotension,Bradycardia,persistent hypertension | post-treatment till 24 hours |
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