Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Conditions

• Eclampsia Preeclampsia
• Severe Preeclampsia

Eligibility Criteria

Sex

FEMALE

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Levetiracetam — DRUG
  1g oral loading dose followed by 300mg q 8 hours beginning 8 hours after loading dose.
• magnesium sulfate — DRUG
  4gram bolus followed by 2g per hour continuous infusion

Study Details

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 Dates

Start date

Jan 1, 2026

Status verified

Oct 2025

Primary completion

Dec 31, 2033

Completion

Jul 31, 2034

Study Design

Enrollment

1,240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Levetiracetam Arm
  This experimental arm will receive oral levetiracetam 3 times daily after an initial loading oral dose.
• Active Comparator: Magnesium Sulfate Arm
  This arm will receive standard treatment- a loading dose of magnesium sulfate followed by a continuous infusion that is the current standard of care (4 gram bolus followed by 2grams per hour continuous infusion).

Primary Outcome Measure

Eclamptic Seizure [ Time Frame: From enrollment until then end of monitoring at 6 weeks postpartum. ]

Central Contacts

• Todd Lovgren, MD
  1+402-815-1970
  [email protected]
• Joshua Dahlke, MD
  1+402-815-1970
  [email protected]

Locations (1)

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