Clinical trial NCT02684513: Impact of Oral Carbohydrate Consumption Prior to Cesarean Section
Official title: Impact of Oral Carbohydrate Consumption Prior to Cesarean Section on Preoperative Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Keywords: Well-being
Quality of Recovery
Maternal complications
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Heermann Anesthesia Foundation
First posted: 2016-02-18
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale.
timeFrame: Change from baseline to one hour
Secondary outcomes:
measure: Changes between the maternal groups assessed by the mean arterial pressure (MAP) recordings in every 5 minute period
timeFrame: At time of surgery to the conclusion
measure: Number of participants admitted to maternal intensive care unit between the groups
timeFrame: Up to 15 days
measure: Number of days in the hospital for each participant between the groups
timeFrame: Up to 15 days
measure: Number of postoperative infections between the groups
timeFrame: Up to 15 days
measure: Neonates with plasma glucose level of less than 45 mg/dL between the groups
timeFrame: Baseline
measure: Number of neonates with a 5 minute Apgar score less than 7 between the groups
timeFrame: 5 minutes
measure: Number of neonates on ventilation for 6 hours or greater between the groups
timeFrame: 6 hours
measure: Number of neonates diagnosed with an infection between the groups.
timeFrame: Baseline
measure: Number of neonates admitted to the intensive care unit (ICU) between the groups
timeFrame: Baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Adam Wendling, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.