Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Starting soon · Phase 3

Conditions studied: Severe Preeclampsia, Eclampsia Preeclampsia

In brief

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.

Key facts

Study ID

NCT07220902

Run by

Nebraska Methodist Health System

People needed

1240

Starts

2026-01-01

Expected to finish

2034-07-01

Last updated by the study team

2025-10-24

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant or postpartum women aged 19 years or older
• Diagnosed with preeclampsia with severe features, superimposed preeclampsia or HELLP syndrome
• At risk for eclampsia and eligible for seizure prophylaxis
• Less than 2 hours exposure to magnesium sulfate or greater than 48 hours since last dose.
• Admitted or plan to proceed with delivery

You may not qualify if…

• <32 weeks estimated gestational age
• History of epilepsy or seizure disorders unrelated to pregnancy
• Allergy or contraindication to Levetiracetam or Magnesium Sulfate
• Severe renal impairment (Oliguria <120ml in 4 hours)
• Plan for neonatal comfort care

Where it is running

• Methodist Women's Hospital — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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