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临床试验/NCT03494868
NCT03494868终止不适用

Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
19
试验地点
1
主要终点
Oral glucose tolerance test

研究概览

简要总结

Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Oral carbohydrate loading has been shown to attenuate the development of insulin resistance in the non-pregnant population undergoing many different types of surgery. Pregnant women have an increase in insulin resistance and therefore may further benefit from a preoperative carbohydrate load prior to cesarean delivery. Although woman in the UK receive a carbohydrate drink prior to elective cesarean delivery, the metabolic effects of these drinks on the mother and neonate have not been evaluated.

详细描述

Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Perioperative insulin resistance results in hyperglycemia which can lead to increased infectious complications, morbidity, and mortality.2,3 Significant research has occurred in the non-pregnant population utilizing preoperative oral carbohydrate loading to attenuate the development of insulin resistance. In a recent meta-analysis, Awad and colleagues 2 found that a preoperative carbohydrate drink may be associated with reduced length of stay and a reduction in postoperative insulin resistance in patients undergoing major abdominal surgery.

Approximately 1.3 million women undergo cesarean delivery (CD) annually in the United States. 4 CD is the most common inpatient surgery in the United States. In the UK, there are recommendations to implement enhanced recovery after obstetric surgery. Implementation of enhanced recovery supports the National Health Service Quality, Innovation, Productivity, and Prevention programme with the aim of improving quality of care while reducing costs. As part of the enhanced recovery pathway, pregnant women are receiving a preoperative carbohydrate drink. There is a paucity of research looking at the metabolic effects of this carbohydrate load in the pregnant woman and her neonate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • •ASA physical status II-III women presenting for scheduled, elective cesarean delivery under neuraxial anesthesia
  • •Singleton gestation at term (37-42 weeks)
  • •Ages 18-50

排除标准

  • •Preexisting diabetes (Gestational diabetes, Type I DM, Type II DM)
  • •Taking insulin-sensitizing or other medications known to influence glucose or fatty acid metabolism.
  • •Kidney, heart, or liver disease. Severe lipid disorders.
  • •History of bariatric surgery
  • •Pre-pregnancy BMI >40
  • •Prolonged period of time (>4 hours) between ingestion of carbohydrate drink and surgery
  • •Four or more repeat cesarean sections

研究组 & 干预措施

Fasting

No Intervention

Fasting prior to elective cesarean section delivery (standard of care)

Carbohydrate Drink

Experimental

Subjects will drink 2 carbohydrate drinks prior to elective cesarean section delivery

干预措施: Carbohydrate Drink (Dietary Supplement)

结局指标

主要结局

Oral glucose tolerance test

时间窗: 24 hours postoperatively

glucose, insulin

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily E. Sharpe, M.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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