Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Rate of active stage of labor
研究概览
简要总结
Prolonged labor is associated with adverse maternal and fetal outcomes including infection, postpartum hemorrhage and increased NICU admission. One of the most common indications for cesarean section in the US is prolonged labor. Maternal positioning through labor facilitated by birthing balls is believed to help facilitate labor. Current data is inconclusive on whether or not the use of birthing balls is advantageous in a statistically significant manner.
In this prospective randomized controlled trial, participants will be randomly selected to receive either the experimental intervention (repositioning peanut ball during labor) or the control intervention (the standard therapy of traditional repositioning during labor).
Primary outcome: Time of active labor to delivery with and without use of the peanut ball.
Secondary outcome: Cesarean section frequency.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fetus must be vertex in position at the time of admission to L&D
- •Pregnant patients age 16 years old and above
- •Singleton pregnancy (ie. one fetus)
- •Patients who receive induction and augmentation of labor may be included
- •Include both nulliparous and multiparous women
- •Patients with HTN, diabetes, and obesity at any point in their pregnancy may be included
- •Patients may be included in the study regardless of whether or not they received an epidural
- •Patients who have been randomly assigned to receive a peanut ball must be placed on the peanut ball at 6cm dilation, not earlier.
- •Patients who present to L&D dilated to 4cm may be included
排除标准
- •TOLACs and VBACs will be excluded
- •Multiple gestation will be excluded
- •Category 3 fetal tracing will be excluded
- •Chorioamnionitis will be excluded
- •Patients who present to L&D at 6cm cervical dilation will be excluded
- •Patients placed on the peanut ball before 6cm cervical dilation will be excluded
- •Patients with fetal malpresentation will be excluded
研究组 & 干预措施
Traditional Positioning
Participants who are randomly assigned to NOT receive a peanut ball will undergo placement on a wedge pillow and/or traditional positioning during their labor progression at 6cm cervical dilation.
干预措施: Traditional positioning (Other)
Peanut Ball Positioning
Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation.
干预措施: Positioning with peanut ball (Device)
结局指标
主要结局
Rate of active stage of labor
时间窗: Expected <6 hours
Length of time from progression of 6cm cervical dilation to 10cm
次要结局
- Cesarean section rate(< 48 hours)
研究者
Rachel Nelson
Co-Principal Investigator
University of Tennessee