Impact of Oral Carbohydrate Consumption Prior to Cesarean Section

NCT ID: NCT02684513

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-14
• Study Completion Date: 2019-04-04

Brief Summary

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.

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.

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Oral Carbohydrate Beverage

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: ACTIVE_COMPARATOR

Rehydration beverage

Intervention Type: DIETARY_SUPPLEMENT

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.

Fasted Controls

Subjects assigned to this group will fast for ≥8 hours prior to surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Preoperative beverage; Preoperative beverage

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Heermann Anesthesia Foundation

UNKNOWN

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Wendling, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32025843 (View on PubMed)

Other Identifiers

IRB201501150

Identifier Type: -

Identifier Source: org_study_id