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临床试验/NCT06505915
NCT06505915已完成不适用

Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send': A Randomised Trial of Two Different Fasting Protocols at Elective Caesarean Delivery

The Rotunda Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
General well-being of the patient

研究概览

简要总结

Women undergoing elective caesarean deliveries are fasted for long periods prior to surgery. Recently, Rotunda Maternity Hospital have started using two fasting protocols at the Rotunda prior to elective caesarean section, one uses carbohydrate drinks, and the other encourages women to sip water until they are called to the operating theatre. The evidence to support the use of either one is very limited. This study would help streamline one of the protocols.

详细描述

This is a study focused on comparing fasting policies that are in use at the Rotunda.

Investigators wish to determine the best fasting policy for women at elective caesarean delivery by focusing on assessing outcomes related to the patient experience.

A 'Sip til send' fasting policy means women may drink clear fluid up until the time they are called from the ward to come to theatre for their elective caesarean delivery. This policy was implemented at the Rotunda in 2022 and was studied prospectively, investigators demonstrated improvements in the comfort that women experience in their perioperative journey, compared to a traditional fasting protocol where women must fast for many hours for both fluids and solids before they come to theatre.

It has been shown that oral carbohydrate intake may improve outcomes in general and cardiac surgeries, but there is very limited evidence in obstetrics. The Rotunda is increasingly providing women with carbohydrate drinks prior to CD. These drinks are consumed by the patient on the morning of surgery as part of an enhanced recovery after surgery (ERAS) package. There is little evidence to support the use of carbohydrate drinks, but current thinking is that they may increase energy and comfort and reduce metabolic changes due to prolonged fasting.

Pregnant women are more vulnerable to the side effects related to the extended fasting due to the accelerated fasting in the third trimester of pregnancy after an overnight fast pre-operatively. Carbohydrate reserves are rapidly exhausted, causing hypoglycemia, increased urine nitrogen secretion (indicating muscle catabolism), and increased urinary ketone body concentration. It has been recommended that Mothers in their third trimester avoid skipping meals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

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.
  • Planned general anaesthesia.
  • Elective caesarean delivery at a gestation of less than 37 weeks.
  • Low birth weight 2.5 kg (IUGR)
  • BMI greater than 45 kg/m2
  • Women with severe gastro-oesophageal reflux disease

结局指标

主要结局

General well-being of the patient

时间窗: Immediately Preoperatively

Compare fasting protocols using a 0-10 Visual Analogue Score (VAS) for patient-focused comfort outcomes, including anxiety, thirst, hunger, nausea, and comfort. Each of them would be scored from 0 to 10, 0 being nothing and 10 being the maximum score relative to the feeling

次要结局

  • General well-being of the patient(24 hours post operative)

研究者

发起方
The Rotunda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rana Muhammad Shoaib Sadiq

Anaesthesia Fellow

The Rotunda Hospital

研究点 (1)

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