Use of Peanut Labor Ball for Pelvic Positioning for Nulliparous Patients Following Epidural
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Delivery Rate
研究概览
简要总结
The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after epidural anesthesia in patients who have never given birth. The study will measure the impact on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or forceps use), and third or fourth degree laceration rates. This study will determine the impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and one with traditional wedge and pillow positioning. If benefits related to use of the PLB can be demonstrated, it is our intention that each labor room will be stocked with a PBL for use as standard of care.
This study will test the following hypotheses:
- The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal delivery rate in low risk nulliparous patients who receive epidural anesthesia compared to similar cohort using traditional wedge and pillow positioning.
- Using the PLB will impact the amount of time from epidural placement to complete dilation and the time of second stage of labor, when compared with the control cohort.
- Use of the PLB will impact the third and fourth degree laceration rates when compared with the control cohort.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any nulliparous woman age ≥18 years presenting in labor (or for induction of labor) with:
- •Gestation: 37 0/7weeks- 41 6/7weeks -early, full, and late term gestations (ACOG, 2013).
- •Single gestation
- •Vertex presentation
- •Plans to deliver with epidural anesthesia
排除标准
- •A complication of pregnancy at the time of admission (including known fetal anomalies or placental anomalies)
- •Any muscular or skeletal limitations of the patient that does not allow for positioning with the peanut labor ball (PLB)
- •An inability to speak or understand English language
- •Preterm gestation: <36 6/7 weeks or Post-term >42 0/7weeks
- •A multiple gestation
- •Non-vertex presentation
- •Diabetes including Gestational Diabetes Mellitus (GDM)
- •Order for magnesium sulfate infusion
- •Plan for delivery without epidural
- •Planned cesarean delivery
结局指标
主要结局
Delivery Rate
时间窗: .5-72 hours
Rate of patients who deliver by cesarean section
次要结局
- Dilation to Second Stage Labor(thirty minutes after epidural given to birth of baby)