Clear Liquids vs Enhanced Clear Liquids; Effect on Labor Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Time from admission to delivery
研究概览
简要总结
The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.
详细描述
Patients will be randomized to placebo or experimental arm of study. In the placebo arm, patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit juices, and plain soup broth. The experimental arm will receive the standard clear liquid diet, and in addition will receive Accel Gel every 3 hours while in labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Usual Clear Diet
This intervention consists of soup broth, variety of juices (apple, cranberry, grape), ginger ale, water, and ice.
干预措施: Usual clear diet (Dietary Supplement)
Accel Gel
This intervention is an enhanced clear liquid gel is Accel Gel, produced by PacificHealth Labs of Matawan, NJ. This gel has 4:1 carb to protein ratio formula, and ingredients that are not contraindicated in pregnancy (only the flavors with minimal caffeine are used).
http://www.pacifichealthlabs.com/accel-gel-all-natural-rapid-energy-gel-product.html
干预措施: Accel Gel (Dietary Supplement)
结局指标
主要结局
Time from admission to delivery
时间窗: Participants will be followed during labor until delivery, an expected range of 1-48 hours
Up to 3 days from time of admission
次要结局
- delivery in <24 hours(Participants will be followed during labor until delivery, an expected range of 1-48 hours)
- Urine Ketones(Participants will be followed during labor until full dilation, an expected range of 1-48 hours)
- Duration of second stage of labor(Participants will be followed during labor until delivery, an expected range of 1-48 hours)
- cesarean delivery(Participants will be followed during labor until delivery, an expected range of 1-48 hours)
- rate of composite adverse GI outcome (vomiting or diarrhea)(Participants will be followed for the duration of hospital stay, an expected average of 5 days)
- patient satisfaction with diet(Participants will be followed during labor until delivery, an expected range of 1-48 hours)