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

Phase 1

Not yet recruiting

• Conditions: Severe Preeclampsia
• Interventions: Drug: maintenance magnesium sulphate1g/h; Drug: maintenance magnesium sulphate2g/h

• Registration Number: NCT06486025
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed 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

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study Start: 2024-07-01
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-09-15
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Sulphate 1g/hr	maintenance magnesium sulphate1g/h	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.
Magnesium Sulphate 2g/hr	maintenance magnesium sulphate2g/h	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.

Primary Outcome Measures

Name	Time	Method
serum magnesium level	24 hours	Maternal Serum Magnesium Level after 24 hours of magnesium sulphate infusion