Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial "LEVMag Trial"
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,240
- 试验地点
- 1
- 主要终点
- Eclamptic Seizure
研究概览
简要总结
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.
详细描述
Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial Study Protocol
- Study Title: Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure: A Randomized Controlled Trial (LEVMag Trial)
- 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 adverse events between the two study medications.
- Study Design
- Design: Prospective, randomized, controlled, open-label, non-inferiority trial.
- Setting: Single Urban Level III Obstetric Facility
- Duration: 72-84 months (including recruitment, treatment, and follow-up).
- Study Population
- Inclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •<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
研究组 & 干预措施
Levetiracetam Arm
This experimental arm will receive oral levetiracetam 3 times daily after an initial loading oral dose.
干预措施: Levetiracetam (Drug)
Magnesium Sulfate Arm
This arm will receive standard treatment- a loading dose of magnesium sulfate followed by a continuous infusion that is the current standard of care (4 gram bolus followed by 2grams per hour continuous infusion).
干预措施: magnesium sulfate (Drug)
结局指标
主要结局
Eclamptic Seizure
时间窗: From enrollment until then end of monitoring at 6 weeks postpartum.
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.
次要结局
未报告次要终点
研究者
Todd Lovgren
Primary Investigator
Nebraska Methodist Health System