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Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure
Sponsor: Nebraska Methodist Health System
Summary
The goal of this study is to compare levetiracetam to magnesium sulfate for the prevention of eclamptic seizures in pregnant persons with severe preeclampsia that are 32 or more weeks pregnant. This is an equivalence study so our primary goal is to see no difference in the incidence of seizure in the two groups. Since side effects can be a significant problem with magnesium sulfate and these patients are at significant risk of life threatening complications, we also plan to evaluate several secondary outcomes in the mothers and the babies, including: severe allergic reaction, magnesium toxicity, ICU admission, hospital readmission, transfusion for any reason, pulmonary edema, cardiomyopathy, Posterior Reversible Encephalopathy Syndrome, eclamptic seizure, loss of vision, stroke, renal injury requiring dialysis, cardiac arrest, maternal death, unexpected stillbirth or neonatal death, NICU admission, Apgars and length of neonatal respiratory support.
Official title: Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial "LEVMag Trial"
Key Details
Gender
FEMALE
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1240
Start Date
2026-01-01
Completion Date
2034-07
Last Updated
2025-10-24
Healthy Volunteers
No
Interventions
Levetiracetam
1g oral loading dose followed by 300mg q 8 hours beginning 8 hours after loading dose.
magnesium sulfate
4gram bolus followed by 2g per hour continuous infusion
Locations (1)
Methodist Women's Hospital
Omaha, Nebraska, United States