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临床试验/NCT02835339
NCT02835339已完成4 期

Randomized Trial of Magnesium Sulfate in Obese Preeclamptic Women

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年7月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Maternal Serum Magnesium Level at 4 Hours After Administration

研究概览

简要总结

The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

详细描述

The purpose of this study is to learn how medications participant will receive in the course of their delivery are metabolized (broken down by the body). The investigators hope to learn more about the way drugs are metabolized by pregnant women, and how those drugs are distributed in the blood and body compartments and cleared in the urine, and how maternal body weight affects the metabolism. With this information the investigators will be able to develop a treatment regimen considering factors in the body that affect magnesium levels so that the investigators can improve treatment of pregnant women. The goal of the study is to understand how different dosing of magnesium sulfate affects blood levels of the magnesium in larger women.

Magnesium sulfate is generally given to patients to protect the mother against seizures in the case of preeclampsia. Different hospitals in the United States use different doses of magnesium sulfate. Participants will receive one of two accepted doses of magnesium sulfate for preeclampsia. The dose is usually 4g - 6g at the start, with another dose of 2-3 g every hour until 24 hours after delivery. Participants will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete. Participants will receive magnesium sulfate in the course of their normal clinical care whether or not they participate in this study.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women who are ages 18-45
  • 32-42 weeks' pregnant
  • Prescribed magnesium sulfate for preeclampsia
  • BMI ≥35 kg/m2

排除标准

  • Pregnant women < 32 weeks' pregnant
  • Women who are on dialysis

研究组 & 干预措施

MgSO4 4g load, 1g/hr infusion

Active Comparator

Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.

干预措施: Magnesium sulfate 4g loading dose, 1g/hr infusion (Drug)

MgSO4 6g load, 2g/hr infusion

Experimental

Once their obstetrician prescribes magnesium sulfate, participant will be assigned by 50/50 chance to one of two treatment regimens. Participant will be assigned to either a dose of 4 g at the start, followed by 1g every hour; or a dose of 6 g at the start, followed by 2g every hour until treatment for preeclampsia is complete.

干预措施: Magnesium sulfate 6g loading dose, 2g/hr infusion (Drug)

结局指标

主要结局

Maternal Serum Magnesium Level at 4 Hours After Administration

时间窗: 4 hours

magnesium level in mg/dL

次要结局

  • Maternal Serum Magnesium Level at Time of Delivery(Within 20 minutes of delivery)
  • Maternal Side Effects(4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Brookfield

Assistant Professor

Oregon Health and Science University

研究点 (1)

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