Preoperative Carbohydrate Drink Prior to Elective Caesarean Section: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Neonatal cord blood glucose
研究概览
简要总结
Prior to caesarean section, patients should fast from solid food for 6 hours and from clear fluids for 2 hours. Carbohydrate drinks can also be consumed up to 2 hours before surgery. These drinks have been shown to improve patient well-being after surgery and may potentially improve the neonatal blood glucose level after delivery and reduce the risk of a low blood glucose level. This study aims to assess the influence of pre-operative carbohydrate drinks on blood glucose levels of the baby at delivery.
详细描述
Patients recruited to the study will be randomised to one of 3 groups.
Group 1 will receive standard care as per our current practice. This includes fasting from solids for 6 hours prior to surgery and clear fluids for up to 2 hours prior to surgery.
Group 2 will receive a carbohydrate (CHO) drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this CHO drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Group 3 will receive an apple juice drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this apple juice drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Before the start of surgery, the patients non-dominant hand grip strength will be assessed using the dynamometer. Their subjective sense of thirst and hunger will be assessed. Their fasting times for food and fluids will be recorded. The patients' blood glucose will be measured from a blood sample as their intravenous cannula is inserted. The maternal urinary ketones will be measured from a urine sample upon insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Patient will not be blinded to which arm they have been allocated to. Outcome assessors will be unaware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective caesarean section for singleton pregnancy under neuraxial anaesthesia.
- •Subjects able to give informed consent and willing to comply with the study protocol.
- •Subjects must be greater than 18 years old.
排除标准
- •Diabetes Mellitus - including gestational diabetes.
- •Known foetal abnormality.
- •General anaesthesia.
- •Gestation < 37 weeks.
- •Steroids received within 4 days of delivery.
- •Low birth weight 2.5 kg (IUGR)
- •BMI > 40 kg/m2
结局指标
主要结局
Neonatal cord blood glucose
时间窗: 0 hours
A blood sample of the neonatal cord will be checked immediately after delivery.
次要结局
- Maternal subjective sense of thirst prior to the start of caesarean section.(0 hours)
- Resumption of oral diet post caesarean section.(24 hours)
- Neonate tolerating 1st oral feeding.(0-2 hours)
- Maternal subjective sense of hunger prior to the start of caesarean section.(0 hours)
- Post-operative nausea and vomiting (PONV)(24 hours)
- Number of neonatal rescue oral glucose sachets given.(6 hours)
- Maternal blood glucose(0 hours)
- Neonate requiring ICU admission and treatment for hypoglycemia(6 hours)
- Maternal urinary ketones(0 hours)
- Maternal quality of recovery(24 hours)
- Resumption of fluids post caesarean section.(24 hours)
- PONV requiring treatment(24 hours)
- Pain scores(24 hours)
- Breastfeeding success(24 hours)
研究者
Ruairi Irwin
Anaesthesia SpR
Coombe Women and Infants University Hospital