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临床试验/NCT04474704
NCT04474704已完成不适用

Use of Cheetah® Non-invasive Cardiac Monitoring System to Guide Discontinuation of Postpartum Magnesium Sulfate in Women With Severe Preeclampsia: A Pilot Randomized Control Trial

Ohio State University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2021年2月22日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single site pilot randomized, controlled, trial randomizing patients with PE with severe features to one of 2 groups:

  • 24 hours of postpartum magnesium sulfate (current arbitrary standard of care)
  • Using the Cheetah® device to aid in an individualized duration of magnesium sulfate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Preeclampsia with severe features, diagnosed using the American Congress of Obstetricians and Gynecologists (ACOG) standard criteria 4 requiring magnesium sulfate
  • •Females older than 18 years of age
  • •Singleton pregnancy
  • •Gestational age greater than 24 0/7 weeks
  • •The patient is physically and mentally able to understand the informed consent and is willing to participate in this study
  • •Able to speak English or Spanish

排除标准

  • •Multiple gestation
  • •Prisoners
  • •Patients with chronic renal insufficiency or epilepsy
  • •Known cardiovascular disease
  • •Patients with contraindications to magnesium sulfate use (e.g. myasthenia gravis)
  • •Patients with eclampsia or HELLP syndrome
  • •Contraindications for magnesium sulfate

结局指标

主要结局

Duration of Magnesium Sulfate Use in the Postpartum Period Defined as the Duration in Hours Between Delivery and Discontinuation of Magnesium Sulfate.

时间窗: up to 24 hours postpartum

次要结局

  • Use of Acute Anti-hypertensive Medications(Up to 5 days after delivery)
  • Evaluating Number of Participants With Hospital Readmission for Preeclampsia(up to 4 weeks postpartum)
  • Composite of Postpartum Adverse Outcomes(up to 4 weeks after delivery)
  • Evaluating Incidence of Need to Restart Magnesium Sulfate(up to 1 week postpartum)
  • Need for More Than 1 Dose of Anti-hypertensive Medication(Up to 5 days after delivery)

研究者

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

Maged Costantine

MD, Professor

Ohio State University

研究点 (2)

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