Overview

Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Status:
NOT_YET_RECRUITING
Trial end date:
2034-07-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Nebraska Methodist Health System
Treatments:
Levetiracetam
Magnesium Sulfate