Impact of Oral Carbohydrate Consumption Prior to Cesarean Section
Primary Purpose
Dehydration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral Carbohydrate Beverage
Rehydration beverage
Sponsored by
About this trial
This is an interventional health services research trial for Dehydration focused on measuring Well-being, Quality of Recovery, Maternal complications
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
Sites / Locations
- UF Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Oral Carbohydrate Beverage Group
Rehydration Beverage Group
Fasted Controls
Arm 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.
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.
Subjects assigned to this group will fast for ≥8 hours prior to surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Number of participants admitted to maternal intensive care unit between the groups
Number of ICU admissions during hospitalization between the groups
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02684513
First Posted
February 4, 2016
Last Updated
July 30, 2019
Sponsor
University of Florida
Collaborators
Heermann Anesthesia Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02684513
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 14, 2016 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
April 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Heermann Anesthesia Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
Well-being, Quality of Recovery, Maternal complications
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Carbohydrate Beverage Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Rehydration Beverage Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Fasted Controls
Arm Type
No Intervention
Arm Description
Subjects assigned to this group will fast for ≥8 hours prior to surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Carbohydrate Beverage
Other Intervention Name(s)
Preoperative beverage
Intervention Description
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
Intervention Name(s)
Rehydration beverage
Other Intervention Name(s)
Preoperative beverage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale.
Description
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.
Time Frame
Change from baseline to one hour
Secondary Outcome Measure Information:
Title
Changes between the maternal groups assessed by the mean arterial pressure (MAP) recordings in every 5 minute period
Description
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.
Time Frame
At time of surgery to the conclusion
Title
Number of participants admitted to maternal intensive care unit between the groups
Description
Number of ICU admissions during hospitalization between the groups
Time Frame
Up to 15 days
Title
Number of days in the hospital for each participant between the groups
Description
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.
Time Frame
Up to 15 days
Title
Number of postoperative infections between the groups
Description
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.
Time Frame
Up to 15 days
Title
Neonates with plasma glucose level of less than 45 mg/dL between the groups
Description
First umbilical cord blood sample will be taken for plasma glucose level of less than 45 mg/dL to note hypoglycemia between the groups.
Time Frame
Baseline
Title
Number of neonates with a 5 minute Apgar score less than 7 between the groups
Description
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.
Time Frame
5 minutes
Title
Number of neonates on ventilation for 6 hours or greater between the groups
Description
Number of neonates on ventilation for 6 hours or greater will be recorded.
Time Frame
6 hours
Title
Number of neonates diagnosed with an infection between the groups.
Description
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.
Time Frame
Baseline
Title
Number of neonates admitted to the intensive care unit (ICU) between the groups
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Wendling, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-3003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32025843
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.
Results Reference
derived
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Impact of Oral Carbohydrate Consumption Prior to Cesarean Section
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