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Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

NCT07220902 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1240

Last updated 2025-10-24

No results posted yet for this study

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.

Conditions

  • Severe Preeclampsia
  • Eclampsia Preeclampsia

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

Sponsors & Collaborators

  • Nebraska Methodist Health System

    lead OTHER

Principal Investigators

  • Todd Lovgren, MD · Nebraska Methodist Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2033-12-31
Completion
2034-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220902 on ClinicalTrials.gov