Impact of Oral Carbohydrate Consumption Prior to Cesarean Section

Impact of Oral Carbohydrate Consumption Prior to Cesarean Section on Preoperative Well-being

For more than 15 years, traditional fasting regimens prior to scheduled surgeries have been called into question, yet prolonged preoperative fasting remains common practice. While prolonged fasting is aimed at reducing the risk of pulmonary aspiration, prolonged fasting is uncomfortable, has an inconsistent effect on gastric volumes and acidity and may lead to dehydration without a clear reduction in the incidence of aspiration. Fasting by itself decreases hepatic glycogen stores, induces a state of insulin resistance and impairs cardiovascular function. Yet, prolonged preoperative fasting remains common.

Preoperative oral carbohydrate (CHO) consumption improves insulin sensitivity and decreases the time to return of gut function without increasing gastric volumes or acidity compared to other clear liquids and fasting. Previous work has shown oral CHO consumption improves patient well-being to a greater degree than placebo drink (water or flavored water) and fasted controls. Oral CHO also outperforms a similar volume of intravenous glucose supplementation. These benefits have reduced hospital stays in a variety of surgical models by as much as 20%. Further, preoperative CHO supplementation improved postoperative patient hunger, thirst, anxiety, fatigue and nausea.

The purpose of this research study is to determine if drinking a high carbohydrate beverage before cesarean section surgery can improve patient well-being, compared to patients who drink a low carbohydrate beverage or fast before surgery.

Study Overview

• Status: Completed
• Conditions: Dehydration
• Intervention / Treatment: Dietary supplement: Oral Carbohydrate Beverage; Dietary supplement: Rehydration beverage

Detailed Description

The study hopes to determine if either of two different oral beverages (a higher CHO concentration versus a lower CHO concentration) is superior to routine fasting in terms of preoperative well-being among patients presenting for scheduled cesarean section. Preoperative well-being will be determined by a composite of visual analog scale scores aimed at assessing hunger, thirst, anxiety, fatigue and nausea on the morning of surgery.

Women will be recruited from one of two outpatient obstetric clinics, University of Florida (UF) Health Women's Center - Medical Plaza or UF Health Women's Center. Women presenting for scheduled cesarean section will be provided with an opportunity to participate. Then the women will be randomized into one of three groups: oral carbohydrate beverage (group CHO), re-hydration beverage of an equal volume (group R) or fasted controls (group F). All subjects who consent to participation will have the following recorded: height, weight, age, indication for cesarean section, surgeon, and number of prior cesarean sections.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610-3003
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Full-term (≥37 weeks gestation) with singleton gestation
• Proficient with English language
• Planning on undergoing scheduled cesarean delivery under neuraxial anesthesia

Exclusion Criteria:

• Women with pre-gestational or gestational diabetes mellitus or diabetes present prior to pregnancy
• Women who did not complete a gestational diabetes screening test
• Women who received steroids within the past 7 days prior to delivery
• Women who received magnesium sulfate in the setting of hypertensive disorders of pregnancy
• Women with a history of chronic opioid use
• Preterm pregnancies
• Fetuses with congenital abnormalities or growth restriction
• Multiple gestation
• Women who are American Society of Anesthesiology Class III or higher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Carbohydrate Beverage Group; Subjects assigned to this group will receive 710 mL of a preoperative beverage the evening prior to surgery and 355 mL the morning of surgery.	Dietary supplement: Oral Carbohydrate Beverage; The oral carbohydrate beverage will be consume in a 710 mL amount the evening prior to surgery and then a 355 mL amount the morning of surgery.; Other Names: Preoperative beverage
Active Comparator: Rehydration Beverage Group; Subjects assigned to this group will receive 710 mL of re-hydration beverage the evening prior to surgery and 355 mL the morning of surgery.	Dietary supplement: Rehydration beverage; The rehydration beverage group will be consume in a 710 mL amount the evening prior to surgery and then a 355 mL amount the morning of surgery.; Other Names: Preoperative beverage
No Intervention: Fasted Controls; Subjects assigned to this group will fast for ≥8 hours prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale.	100 mm visual analogue scales for hunger, thirst, anxiety, fatigue and nausea administered on the morning of surgery prior to morning beverage consumption and 60 minutes after the beverage. All measurements will be assessed using the same scale starting at 0 to 100mm with 0 being the worst and 100 being the best and average being 85.	Change from baseline to one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes between the maternal groups assessed by the mean arterial pressure (MAP) recordings in every 5 minute period	Maternal cardiovascular function will be assessed by using the average of all the mean arterial pressure (MAP) recordings in every 5 minute period. This will be measured by using a student's t-test for significant differences between the groups.	At time of surgery to the conclusion
Number of participants admitted to maternal intensive care unit between the groups	Number of ICU admissions during hospitalization between the groups	Up to 15 days
Number of days in the hospital for each participant between the groups	Number of days in the hospital for each participant between the groups. This will be measured by using the chi-square tests to assess the frequency of this outcome between the groups.	Up to 15 days
Number of postoperative infections between the groups	Number of postoperative infections for each participant between the groups. This will be measured by using the chi-square tests to assess the frequency of this outcome between the groups.	Up to 15 days
Neonates with plasma glucose level of less than 45 mg/dL between the groups	First umbilical cord blood sample will be taken for plasma glucose level of less than 45 mg/dL to note hypoglycemia between the groups.	Baseline
Number of neonates with a 5 minute Apgar score less than 7 between the groups	Record of the 5 minute apgar score < 7. Apgar scores are as follows: between 7 and 10, means the neonate is in good shape, between 4 and 6 may need some help breathing, and 3 or less may need immediate lifesaving measures.	5 minutes
Number of neonates on ventilation for 6 hours or greater between the groups	Number of neonates on ventilation for 6 hours or greater will be recorded.	6 hours
Number of neonates diagnosed with an infection between the groups.	Number of neonates with an infection diagnosis. This will be measured by using the chi-square tests to assess the frequency of this outcome between the groups.	Baseline
Number of neonates admitted to the intensive care unit (ICU) between the groups	Number of neonates admitted to the ICU between the groups. This will be measured by using the chi-square tests to assess the frequency of this outcome between the groups.	Baseline

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Heermann Anesthesia Foundation
• Investigators: Principal Investigator: Adam Wendling, MD, University of Florida

Publications and helpful links

General Publications

• Wendling AL, Byun SY, Koenig M, Vasilopoulos T. Impact of oral carbohydrate consumption prior to cesarean delivery on preoperative well-being: a randomized interventional study. Arch Gynecol Obstet. 2020 Jan;301(1):179-187. doi: 10.1007/s00404-020-05455-z. Epub 2020 Feb 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Actual): June 12, 2018
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Well-being; Quality of Recovery; Maternal complications
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: IRB201501150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO