Clinical trial
ALTERNATE DOSING PROTOCOL FOR MAGNESIUM SULFATE IN OVERWEIGHT AND OBESE WOMEN WITH PREECLAMPISA: A RANDOMIZED CONTROLLED TRIAL
Name
Magnesium and Preeclampsia
Description
There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level.
Trial arms
Trial start
2024-07-01
Estimated PCD
2024-09-15
Trial end
2024-10-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
maintenance magnesium sulphate1g/h
Women will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 1 g/h.
Arms:
Magnesium Sulphate 1g/hr
maintenance magnesium sulphate2g/h
Women will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 2 g/h.
Arms:
Magnesium Sulphate 2g/hr
Size
100
Primary endpoint
serum magnesium level
24 hours
Eligibility criteria
Inclusion Criteria:
Women diagnosed with SPET as per criteria of NICE, 2023 guidance
* Age 20-40 years
* BMI \>25kg/m2
* Gestational age \> 28 weeks
Exclusion Criteria:
* Intrauterine Fetal Death (IUFD)
* Hemolysis - Elevated liver enzymes - Low platelets syndrome (HELLP)
* Contraindication to Magnesium Sulfate such as myasthenia gravis, severe renal failure, cardiac ischemia, and heart block
* Serum creatinine levels greater than 1.1 mg/dL.
* Women refusing to participate in the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-07-03
1 organization
1 product
1 indication
Organization
Ain Shams UniversityIndication
preeclampsia