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Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial "LEVMag Trial"

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 20 years
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Divided doses to begin 8 hours after initial 1g loading dose. * Control Arm: Magnesium Sulfate 4gm IV over 15-20min followed by 2gm/hr IV infusion (current hospital protocol). 6."
  • "The last studies comparing magnesium sulfate were performed against Nimodipine, a calcium channel blocker, over 20 years ago and phenytoin around 30 years ago."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 \<120ml in 4 hours) * Plan for neonatal comfort care

Study sites (1)

NE