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临床试验/NCT01672424
NCT01672424已完成不适用

Ultrasound Assessment of Gastric Emptying Following the Addition of a High Protein Drink vs Ice Chips During Labor

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Gastric Emptying

研究概览

简要总结

Hypothesis: The volume of gastric contents will be the same for a high protein drink versus ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring parturient.

Specific Aim: To determine the volume of gastric contents at various time intervals (every 20 minutes for 2 hours) in patients with an epidural that are given a high protein drink versus those that are given ice chips, with ultrasound.

详细描述

Since the 1940s women have had restrictions on oral intake during labor. This idea was first introduced by Mendelson, who raised awareness on the relationship between oral intake during labor and the risk of aspiration of acidic gastric contents if general anesthesia was needed. The aspiration of gastric contents could potentially result in severe maternal morbidity or mortality. As a result, women in labor who receive analgesia are typically restricted to just ice chips in order to prevent aspiration in the rare case that they may require general anesthesia for an emergent or stat cesarean section.

However, recent literature reports that the actual risk of aspiration during labor is extremely low. The risk of aspiration is minimized due to improved general anesthetic techniques involving the use of non-particulate antacids to neutralize gastric acidity and rapid sequence induction to quickly secure the patients airway. Many countries have lenient policies on NPO status during labor, including the Netherlands and United Kingdom, who allow solid food intake during this period.

The policy of "nothing by mouth" during labor and the relationship of aspiration of gastric contents were explored by Mendelson. He experimented on rabbits to explore the effects of gastric contents on their lungs. The rabbits only died when they aspirated material containing hydrochloric acid, and no deaths were due to aspiration of fluids with a neutral pH. Therefore, if oral intake in labor were to be permitted, the ideal characteristics would be for the substance to be in liquid form, isotonic, normothermic, pH of 7.4, and have a low residue.

Labor can be compared to continuous moderate aerobic exercise and these women can experience a state of accelerated starvation. This state of starvation results in the production of ketones for an alternative source of energy. There is much debate about whether this production is harmful to the mother or fetus. A study done by Kubli in 2002 evaluated the effects of isotonic sports drinks and the production of ketones. The drinks decreased ketosis but proved no benefit regarding labor outcome (i.e. length of labor, spontaneous delivery rate). It is important to note that isotonic sports drinks do not contain a significant amount of protein.

It is common for many women in labor to experience nausea and emesis. Protein intake during labor may have a beneficial effect in the prevention of nausea and emesis. The feeling of nausea is experienced when stomach muscles contract irregularly and protein has been shown to re-establish a normal, steadier, and slower rhythm. Protein has been believed to decrease incidence of nausea by decreasing these so-called gastric arrhythmias more so than a carbohydrate meal can (i.e. non-beneficial effect of isotonic sports drinks). It has also been shown that high protein intake decreases nausea and emesis in patients receiving cancer chemotherapy. Furthermore, it has been determined that administration of a protein-rich intake prevents nausea whether given 5 minutes or 45 minutes prior to the nauseating stimuli (i.e. cancer chemotherapy).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital of UPMC will be eligible to participate in the study
  • All participants will be recruited at Magee-Womens Hospital
  • All women must present ≤ 5cm cervical dilatation at the time of epidural insertion
  • > 36 weeks gestation
  • Singleton pregnancy
  • Vertex presentation
  • NPO ≥ 4 hours prior to epidural insertion

排除标准

  • Women with diabetes (at increased risk for gastroparesis and fetal macrosomia)
  • Multiple gestation
  • Non-vertex fetal presentation
  • Chronic opioid use (delayed gastric emptying)
  • History of gastric bypass surgery (abnormal anatomical stomach)
  • Severe morbid obesity (BMI > 40kg/m2 due to increased intragastric pressure)
  • History of known obstetric or medical complication (i.e. preeclampsia) that may increase the likelihood of a complicated or operative delivery (i.e. cesarean section)
  • No exclusion criteria shall be based on race and ethnicity
  • Men will not be included since they cannot become pregnant

结局指标

主要结局

Gastric Emptying

时间窗: 2 hours

Gastric emptying will be measured with ultrasounds every twenty minutes for two hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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