Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial "LEVMag Trial"
Nebraska Methodist Health System
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.
Description
Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial Study Protocol 1. Study Title: Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial (LEVMag Trial) 2. Objectives * Primary Objective: To assess whether Levetiracetam is non-inferior to Magnesium Sulfate in preventing eclamptic seizures in laboring and postpartum women with severe preeclampsia and HELLP syndrome. * Secondary Objectives: To compare the safety profiles, maternal and neonatal outcomes, and incidence of adve…
Eligibility
- Age range
- 19+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * \<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 \…
Interventions
- DrugLevetiracetam
1g oral loading dose followed by 300mg q 8 hours beginning 8 hours after loading dose.
- Drugmagnesium sulfate
4gram bolus followed by 2g per hour continuous infusion
Location
- Methodist Women's HospitalOmaha, Nebraska