Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age19+
SponsorNebraska Methodist Health System

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

<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)

Trial design

Treatments tested in this trial

  • Levetiracetam
  • magnesium sulfate

Treatment groups

1,240 Participants
are divided into 2 treatment groups