Magnesium SulfateNCT04539379
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate
A study testing Magnesium sulfate and Labetolol in people with Magnesium Sulfate and Labetalol, run by Zagazig University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Magnesium Sulfate, Labetalol
- What is being tested?
- Magnesium sulfate and Labetolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 )
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine,Zagazig University
Zagazig, Zagazig, Elsharkia,egypt, 44519
About this study
Official title: Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler
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
Read the 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.
- Conditions
- Magnesium Sulfate, Labetalol
- Being tested
- Magnesium sulfate, Labetolol
- Keywords
- magnesium sulfate, labetalol, severe preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
intravenous infusion
LabetololDrug
Also called (Trandate™,)
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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.. Receives: Drug: Magnesium sulfate |
| labetolol | Active comparator | 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. Receives: Drug: Labetolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean velocity
mean velocity of middle cerebral artery
Measured: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
Secondary outcomes (6)
mean end diastolic velocity
mean end diastolic velocity of middle cerebral artery
Measured: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
pulsatility index
pulsatility index of middle cerebral artery
Measured: 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
Measured: 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
Measured: 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)
Measured: post-treatment one and six hours after drug administration.
adverse effects of the study drugs
hypotension,Bradycardia,persistent hypertension
Measured: post-treatment till 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Oct 2020
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnesium SulfateStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- Howida A kamal, M.D, Study director, zagazig U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539379
- Sponsor's protocol ID
- 6353
- Status last verified
- Nov 2022
- First submitted
- 30 Aug 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37074522
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients Using Transcranial Doppler
- ClinicalTrials.gov ID
- NCT04539379
- Acronym / sponsor ID
- 6353
- Conditions
- Magnesium Sulfate, Labetalol
- Keywords
- magnesium sulfate, labetalol, severe preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnesium sulfate | Active comparator | Drug: Magnesium sulfateintravenous 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 | Drug: LabetololThe 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateintravenous infusion | Drug | magnesium sulfate |
| LabetololAlso: (Trandate™,)intravenous infusion | Drug | labetolol |
Primary outcome
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
6 secondary outcomes
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.
pulsatility index
Time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
cerebral perfusion pressure
Time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.
occurrence of seizures
Time frame: 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
Time frame: post-treatment one and six hours after drug administration.
adverse effects of the study drugs
Time frame: post-treatment till 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 37074522Mowafy 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howida A kamal, M.D study director
zagazig U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate and Labetolol in people with Magnesium Sulfate and Labetalol, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean velocity (time frame: basal measurements before administration of the study drugs then at post-treatment one and six hours after drug administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04539379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.