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

ALTERNATE DOSING PROTOCOL FOR MAGNESIUM SULFATE IN OVERWEIGHT AND OBESE WOMEN WITH PREECLAMPISA: A RANDOMIZED CONTROLLED TRIAL

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06486025

Enrollment

100

Registered

2024-07-03

Start date

2024-07-01

Completion date

2024-10-01

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Preeclampsia

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

Interventions

DRUGmaintenance 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.

DRUGmaintenance 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
serum magnesium level	24 hours	Maternal Serum Magnesium Level after 24 hours of magnesium sulphate infusion

Contacts

Primary ContactRehab Hashem

rehabhashem66@gmail.com01017830916

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026