Pharmacokinetics (PK)/Pharmacodynamics (PD) Modeling of Magnesium Sulfate In the Mother and Exposed Neonate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Maternal and neonatal blood magnesium levels
研究概览
简要总结
Determine significant correlations between maternal serum magnesium levels, and maternal and neonatal outcomes.
详细描述
We will construct a pharmacokinetic and pharmacodynamic model of intravenous magnesium sulfate administered antenatally to expectant mothers and exposed fetuses with the aim of optimizing maternal and fetal outcomes while preventing maternal and neonatal overdosing and morbidity associated with current magnesium treatment protocols. Once we have developed a PK/PD model in our own hospital cohort, we will apply this model to a large existing NICHD database to mathematically calculate optimal dosing protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women ages 18-45 years
- •Magnesium sulfate exposure for preeclampsia, tocolysis, or neuroprotection
- •Neonates (male or female) born at 24-42 weeks gestation
排除标准
- 未提供
研究组 & 干预措施
Neonatal
Neonates born to pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection.
干预措施: Magnesium sulfate infusion (Drug)
Maternal
Pregnant women exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection
干预措施: Magnesium sulfate infusion (Drug)
结局指标
主要结局
Maternal and neonatal blood magnesium levels
时间窗: 24 months
Pregnant women and neonates exposed to magnesium sulfate for preeclampsia, tocolysis, or neuroprotection will have blood samples drawn at set time points around the time of delivery.
次要结局
- Maternal and neonatal side effects(24 months)
研究者
Brendan Carvalho
Associate Professor
Stanford University