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Clinical Trials/NCT03494868
NCT03494868TerminatedNot Applicable

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

Mayo Clinic2 sites in 1 country19 target enrollmentStarted: March 13, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
19
Locations
2
Primary Endpoint
Oral glucose tolerance test

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Oral glucose tolerance test

Time Frame: 24 hours postoperatively

glucose, insulin

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emily E. Sharpe, M.D.

Principal Investigator

Mayo Clinic

Study Sites (2)

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