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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
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 (Trandateā¢,) 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnesium sulfate | Active Comparator | 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.. |
|
| labetolol | Active Comparator | The patients will be given intravenous infusion of labetolol (Trandateā¢, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulfate | Drug | intravenous infusion |
| |
| Labetolol |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| pulsatility index |
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Inclusion Criteria:
Exclusion Criteria:
Singleton Pregnant female complicated with severe preeclampsia
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| Name | Affiliation | Role |
|---|---|---|
| Howida A kamal, M.D | zagazig U | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine,Zagazig University | Zagazig | Zagazig, Elsharkia,egypt | 44519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37074522 | Derived | Mowafy SMS, Medhat MM. Evaluation of intravenous infusion of labetalol versus magnesium sulfate on cerebral hemodynamics of preeclampsia patients with severe features using transcranial doppler. J Clin Monit Comput. 2023 Aug;37(4):951-961. doi: 10.1007/s10877-023-01006-4. Epub 2023 Apr 19. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D007741 | Labetalol |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Drug |
intravenous infusion |
|
|
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. |
| 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. |
| 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. |
| 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. |
| adverse effects of the study drugs | hypotension,Bradycardia,persistent hypertension | post-treatment till 24 hours |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |