Protocols for Magnesium Sulfate Maintenance Dose in Overweight and Obese Women Diagnosed With Preeclampsia

Ain Shams University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Severe Preeclampsia

Treatments: Drug: maintenance magnesium sulphate2g/h; Drug: maintenance magnesium sulphate1g/h

Study type: Interventional

Funder types: Other

Identifiers

NCT06486025

Magnesium and Preeclampsia

Details and patient eligibility

About

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.

Full description

Magnesium sulfate is used in pre-eclampsia to prevent seizures, it is administered in the form of a loading dose and maintenance dose. Maintenance dose of magnesium sulfate in pre-eclampsia varies in literature (1-3gms/hour). 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. This study will evaluate whether overweight and obese women need higher maintenance doses to reach therapeutic level of magnesium sulfate in serum.Preeclampsia is a serious pregnancy complication characterized by hypertension, proteinuria and signs of damage to another organ system, often the kidneys, occurring after 20 weeks of gestation

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Magnesium Sulphate 1g/hr

Active Comparator group

Description:

Women in this group will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 1 g/h.

Treatment:

Drug: maintenance magnesium sulphate1g/h

Magnesium Sulphate 2g/hr

Active Comparator group

Description:

Women in this group will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 2 g/h.

Treatment:

Drug: maintenance magnesium sulphate2g/h