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NOT YET RECRUITING
NCT07220902
PHASE3

Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Sponsor: Nebraska Methodist Health System

View on ClinicalTrials.gov

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

DRUG

Levetiracetam

1g oral loading dose followed by 300mg q 8 hours beginning 8 hours after loading dose.

DRUG

magnesium sulfate

4gram bolus followed by 2g per hour continuous infusion

Locations (1)

Methodist Women's Hospital

Omaha, Nebraska, United States