NCT02642588撤回不适用
Effect of a Commercially Available Carbohydrate Rich Gel on Maternal Fatigue: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Fatigue
研究概览
简要总结
Women in active labor will be given energy gel at 45-60 minute intervals and their fatigue level will be compared to women receiving usual practice care i.e. clear liquids only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients must be 18 years or older as well as willing and able to provide informed consent
- •Patients with BMI < 35 kg/m^2
- •Gestational age >37 weeks
排除标准
- •- Patients younger than 18 years,
- •Patients unable or unwilling to provide informed consent,
- •Patients who are illiterate,
- •Patients who are non-English speaking or reading,
- •Patients who are University Hospital employees,
- •Patients undergoing induction of labor for maternal or fetal indications other than elective induction after 39 weeks or induction for post-term pregnancy
- •Multi-fetal gestations (>1 intrauterine pregnancy),
- •Patients with a history of GI disorders such as hyperemesis gravidarum, inflammatory bowel disease or irritable bowel syndrome
- •Patients with an increased risk of aspiration such as BMI >35 kg/m^2, severe GERD, gastroesophageal motility disorders,
- •Patients with acute or chronic platelet dysfunction (e.g.: idiopathic thrombocytopenic purpura, HELLP syndrome) which may necessitate need for general anesthetic for Cesarean delivery
- •Patients with history of peptic ulcer disease,
- •Patients who have a contraindication to epidural placement and would require general anesthestetic in event of Cesarean delivery
- •Patients with suspected or proven placenta accreta, increta or percreta,
- •Patients with excessive nausea or vomiting during labor
- •Patients with a history of food allergies or allergies to specific components found in the energy gel.
结局指标
主要结局
Fatigue
时间窗: every 2 hours until delivery
evaluated by visual analog scale
duration of labor
时间窗: from start of active phase until delivery
will measure time to delivery and duration of 2nd stage of labor
次要结局
未报告次要终点
研究者
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