Evaluation of the Use of Leg Elevation on a Peanut Ball to Prevent Hypotension Following Epidural Anesthesia in Laboring Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Number of Patients With Maternal Hypotension Requiring Treatment
研究概览
简要总结
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:
Arm 1: Patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. She'll remain in this position for approximately 40 minutes.
Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation. She'll remain in this position for approximately 40 minutes.
详细描述
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of leg elevation in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:
Arm 1: Patient will be put in a left tilt position with her hip on a wedge and both legs elevated on a peanut ball. She'll remain in this position for approximately 40 minutes.
Arm 2: Patient will be put in a left tilt position with her hip on a wedge and no leg elevation. She'll remain in this position for approximately 40 minutes.
Outcome variables include occurrence of maternal hypotension or late or prolonged decelerations within the first hour after epidural placement.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Laboring at Good Samaritan Hospital Labor & Delivery Unit
- •37+ weeks gestation
- •Planned vaginal delivery
- •Planned epidural analgesia
排除标准
- •Under 18 years old
- •Does not speak English
- •Unable to consent to involvement in the research study
- •Attended less than 3 prenatal care office visits
- •Diagnosed with fetal demise
- •Diagnosed with fetal anomalies
- •Contraindications to both legs being elevated (ex: fractured bones, lower limb amputation, etc.)
- •Contraindications to receiving 1L of IV fluids
- •Requiring IV hypertensive medications
- •Requiring IV magnesium
结局指标
主要结局
Number of Patients With Maternal Hypotension Requiring Treatment
时间窗: 40 minutes
SBP requiring treatment by the anesthesia provider
Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings
时间窗: 40 minutes
Any late or prolonged decelerations on the fetal heart tracings
次要结局
未报告次要终点