NCT07220902Not yet recruitingPhase 3
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"
Source: ClinicalTrials.gov · Last updated 24 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1240 (estimated)
- First submitted
- 20 Oct 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2033
- Lead sponsor
- Nebraska Methodist Health System
- NCT number
- NCT07220902
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1240
- From 1 Jan 2026 to the primary completion date, 31 Dec 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of epilepsy or seizure disorders unrelated to pregnancy
- Severe renal impairment (Oliguria \<120ml in 4 hours)
Lab values
- Allergy or contraindication to Levetiracetam or Magnesium Sulfate
Age
- \<32 weeks estimated gestational age
Other
- Plan for neonatal comfort care
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Methodist Women's Hospital Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.