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临床试验/NCT04750486
NCT04750486已完成不适用

Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial

Wayne State University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
2
主要终点
Maternal hypotension

研究概览

简要总结

The goal of this study is to determine whether the use of sequential compression devices (lower limb compression) can reduce the rate of maternal hypotension after epidural, and therefore reduce the incidence of fetal heart tracing complications during labor.

详细描述

Maternal hypotension during epidural anesthesia in laboring patients can cause a number of problems for both mother and fetus. Despite standard anesthesia protocols designed to minimize the occurrence of hypotension during epidural placement, approximately 30% of laboring patients will still experience clinically significant hypotension. Maternal hypotension can affect placental blood flow causing fetal bradycardia and academia, as well as maternal symptoms such as dizziness, nausea, and vomiting. Therefore, there is a need for improved management of women in labor at time of epidural placement to avoid negative consequences for mother and fetus. We plan to investigate whether the use of lower limb compression devices at the time of epidural would decrease maternal hypotension.

Pregnant women who request epidural anesthesia during labor will be recruited and enrolled in this single site, randomized controlled trial. Patients will be randomized into either control or sequential compression device (SCD) groups. Following epidural, blood pressures will be measured at 1, 5, 15, 30, 45, and 60 minutes and rates of hypotension with subsequent fetal heart tracing abnormalities will be recorded.

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

入选标准

  • Women with pregnancy at term (greater than or equal to 37 weeks 0 days gestation)
  • Singleton gestation
  • In labor (spontaneous or induced)
  • Requested epidural for pain management

排除标准

  • Any diagnosis of hypertension or cardiovascular disease
  • Any contraindications to lower extremity compression including deep venous thrombosis in past 6 months, infected leg wound, or deformity of lower extremity
  • Any contraindications to epidural placement including severe thrombocytopenia and spinal deformity

结局指标

主要结局

Maternal hypotension

时间窗: Blood pressures measured at 60 minutes following epidural placement.

Determined by maternal blood pressure measurements.

次要结局

  • Fetal heart rate tracing category(Two hours following epidural placement.)
  • Delivery method(length of labor.)

研究者

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

Laura Mroue, MD

Principal Investigator

Wayne State University

研究点 (2)

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