Impact of Oral Carbohydrate Consumption Prior to Cesarean Section

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University of Florida

Status

Completed

Conditions

Dehydration

Treatments

Dietary Supplement: Oral Carbohydrate Beverage
Dietary Supplement: Rehydration beverage

Study type

Interventional

Funder types

Other

Identifiers

NCT02684513
IRB201501150

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

134 participants in 3 patient groups

Oral Carbohydrate Beverage Group
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: Oral Carbohydrate Beverage
Rehydration Beverage Group
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: Rehydration beverage
Fasted Controls
No Intervention group
Description:
Subjects assigned to this group will fast for ≥8 hours prior to surgery.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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