Impact of Oral Carbohydrate Consumption Prior to Cesarean Section

NCT02684513 | Completed

• 1 other identifier: IRB201501150
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration

Keywords

Well-being; Quality of Recovery; Maternal complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Changes between the maternal groups assessed by the mean arterial pressure (MAP) recordings in every 5 minute period

  At time of surgery to the conclusion

• Number of participants admitted to maternal intensive care unit between the groups

  Up to 15 days

• Number of days in the hospital for each participant between the groups

  Up to 15 days

• Number of postoperative infections between the groups

  Up to 15 days

• Neonates with plasma glucose level of less than 45 mg/dL between the groups

  Baseline

Study Arms (3)

Oral Carbohydrate Beverage Group

ACTIVE COMPARATOR

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

Rehydration Beverage Group

ACTIVE COMPARATOR

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

Fasted Controls

NO INTERVENTION

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

Interventions

Oral Carbohydrate Beverage 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.

Also known as: Preoperative beverage

Oral Carbohydrate Beverage Group

Rehydration beverage 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.

Also known as: Preoperative beverage

Rehydration Beverage Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Heermann Anesthesia Foundation: collaborator

Study Sites (1)

UF Health

Gainesville, Florida, 32610-3003, United States

Location

Related Publications (1)

• 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.

  PMID: 32025843 DERIVED

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam Wendling, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 18, 2016
• Study Start: June 14, 2016
• Primary Completion: June 12, 2018
• Study Completion: April 4, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)