跳至主要内容
临床试验/NCT04229043
NCT04229043招募中不适用

Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phillip Hess

Principal Investigator

Beth Israel Deaconess Medical Center

研究点 (2)

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