Lower Limb Compression Prevents Hypotension After Epidural in Labor: A Randomized Controlled Trial
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
- 是
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
Laura Mroue, MD
Principal Investigator
Wayne State University
