Use of a Durometer to Measure Uterine Tone in Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- feasibility of a durometer
研究概览
简要总结
This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery.
详细描述
The most accurate and precise measure of uterine tone is unknown. The most commonly described in vivo method in the literature is a qualitative numeric scoring scale from 0-10. The 0-10 uterine tone score has demonstrated good and excellent inter-rater reliability between 1 and 2 raters respectively, and good inter-rater agreement. Recent data suggests that the 0-10 uterine tone score is well-correlated with clinical assessments of uterine tone.
A handful of studies have used a quantitative "hardness meter", including a Shore durometer, to describe uterine tone in vivo, with promising results. The instrument has not yet been validated in cesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Non-emergent (scheduled) cesarean delivery at University of Chicago Family Birth Center
- •Patients ages 18-50
排除标准
- •Patients undergoing unscheduled (intrapartum) cesarean delivery
- •Ages <18 or >50 years old
- •Intrapartum cesarean hysterectomy
- •Inability to provide independent, informed consent due to impairment or intellectual disability
- •Non-English speaking patients
结局指标
主要结局
feasibility of a durometer
时间窗: within 10 minutes after placental delivery
The primary outcome will be the ability to obtain reliable readings of the 'hardness' of the uterus during a cesarean delivery.
次要结局
- durometer reading(10 minutes after placental delivery)
- correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone")(10 minutes after placental delivery)