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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Levetiracetam
Drug1g oral loading dose followed by 300mg q 8 hours beginning 8 hours after loading dose.
magnesium sulfate
Drug4gram bolus followed by 2g per hour continuous infusion
Treatment groups
1,240 Participants
are divided into 2 treatment groupsGroup A: Levetiracetam ArmExperimental treatment 1 intervention
Group B: Magnesium Sulfate ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Eclamptic Seizure
Seizure based on clinical diagnosis by managing physician. It will be considered and eclamptic seizure for purposes of the study if it occurs following enrollment in the study.
Time frame
From enrollment until then end of monitoring at 6 weeks postpartum.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: