Clinical trial NCT03494868: Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity
Official title: Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insulin Sensitivity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion:

* 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

Exclusion:

* 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

Primary outcomes:
measure: Oral glucose tolerance test
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emily E Sharpe, MD
role: PRINCIPAL_INVESTIGATOR
References: