Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Gastric emptying half time
研究概览
简要总结
To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.
详细描述
This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.
Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group.
Study Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink.
Hypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Gestational age of 36 weeks or greater
- •American Society of Anesthesiology Physical Status 2 or 3
- •Induction of labor or early labor (cervical dilation < 6cm)
- •Singleton gestation
排除标准
- •Recent food ingestion (<3 hours)
- •Preeclampsia
- •Receiving magnesium sulfate
- •Having received narcotics within 12 hours
- •Diabetes mellitus
- •Multiple gestations
- •Active nausea or reflux symptoms
结局指标
主要结局
Gastric emptying half time
时间窗: 60 minutes
The time in minutes that half of the volume of the stomach has emptied
次要结局
- Hunger(60 minutes)
研究者
Phillip Hess
Principal Investigator
Beth Israel Deaconess Medical Center
