ALTERNATE DOSING PROTOCOL FOR MAGNESIUM SULFATE IN OVERWEIGHT AND OBESE WOMEN WITH PREECLAMPISA: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- serum magnesium level
研究概览
简要总结
There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level.
详细描述
Magnesium sulfate is used in pre-eclampsia to prevent seizures, it is administered in the form of a loading dose and maintenance dose. Maintenance dose of magnesium sulfate in pre-eclampsia varies in literature (1-3gms/hour). There is still no evidence of the appropriate dose to be used. Serum magnesium sulfate concentration is not measured regularly, thus we may be using sub-therapeutic level or reaching a toxic level.Overweight and obese women have different pharmacokinetics and different drug distribution, therefore, they may need higher doses of magnesium sulfate to reach therapeutic level. This study will evaluate whether overweight and obese women need higher maintenance doses to reach therapeutic level of magnesium sulfate in serum.Preeclampsia is a serious pregnancy complication characterized by hypertension, proteinuria and signs of damage to another organ system, often the kidneys, occurring after 20 weeks of gestation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with SPET as per criteria of NICE, 2023 guidance
- •Age 20-40 years
- •BMI >25kg/m2
- •Gestational age > 28 weeks
排除标准
- •Intrauterine Fetal Death (IUFD)
- •Hemolysis - Elevated liver enzymes - Low platelets syndrome (HELLP)
- •Contraindication to Magnesium Sulfate such as myasthenia gravis, severe renal failure, cardiac ischemia, and heart block
- •Serum creatinine levels greater than 1.1 mg/dL.
- •Women refusing to participate in the study.
研究组 & 干预措施
Magnesium Sulphate 1g/hr
Women in this group will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 1 g/h.
干预措施: maintenance magnesium sulphate1g/h (Drug)
Magnesium Sulphate 2g/hr
Women in this group will receive a routine loading infusion of 5 g of MgSO4 over 20 minutes, followed by a maintenance dose rate of 2 g/h.
干预措施: maintenance magnesium sulphate2g/h (Drug)
结局指标
主要结局
serum magnesium level
时间窗: 24 hours
Maternal Serum Magnesium Level after 24 hours of magnesium sulphate infusion
次要结局
未报告次要终点