DehydrationNCT02684513
Impact of Oral Carbohydrate Consumption Prior to Cesarean Section
A study testing Oral Carbohydrate Beverage and Rehydration beverage in people with Dehydration, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Oral Carbohydrate Beverage and Rehydration beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2016to 4 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-term (≥37 weeks gestation) with singleton gestation
- Proficient with English language
- Planning on undergoing scheduled cesarean delivery under neuraxial anesthesia
Who cannot join
- 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
Show all 9Show fewer
- Fetuses with congenital abnormalities or growth restriction
- Multiple gestation
- Women who are American Society of Anesthesiology Class III or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Oral Carbohydrate Consumption Prior to Cesarean Section on Preoperative Well-being
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.
Read the 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
- Being tested
- Oral Carbohydrate Beverage, Rehydration beverage
- Keywords
- Well-being, Quality of Recovery, Maternal complications
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Carbohydrate BeverageDietary supplement
Also called Preoperative 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.
Rehydration beverageDietary supplement
Also called Preoperative 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Rehydration beverage |
| Fasted Controls | No intervention | Subjects assigned to this group will fast for ≥8 hours prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At time of surgery to the conclusion
Number of participants admitted to maternal intensive care unit between the groups
Number of ICU admissions during hospitalization between the groups
Measured: Up to 15 days
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.
Measured: Up to 15 days
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.
Measured: Up to 15 days
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.
Measured: Baseline
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.
Measured: 5 minutes
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.
Measured: 6 hours
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start14 Jun 2016
- Primary completion12 Jun 2018
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Heermann Anesthesia Foundation
- Responsible party
- Sponsor
- Investigators
- Adam Wendling, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684513
- Sponsor's protocol ID
- IRB201501150
- Status last verified
- Jul 2019
- First submitted
- 4 Feb 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32025843
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Carbohydrate Consumption Prior to Cesarean Section on Preoperative Well-being
- ClinicalTrials.gov ID
- NCT02684513
- Acronym / sponsor ID
- IRB201501150
- Conditions
- Dehydration
- Keywords
- Well-being, Quality of Recovery, Maternal complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Heermann Anesthesia Foundation
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Carbohydrate Beverage Group | Active comparator | Dietary Supplement: Oral Carbohydrate BeverageSubjects assigned to this group will receive 710 mL of a preoperative beverage the evening prior to surgery and 355 mL the morning of surgery. |
| Rehydration Beverage Group | Active comparator | Dietary Supplement: Rehydration beverageSubjects assigned to this group will receive 710 mL of re-hydration beverage the evening prior to surgery and 355 mL the morning of surgery. |
| Fasted Controls | No intervention | –Subjects assigned to this group will fast for ≥8 hours prior to surgery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Full-term (≥37 weeks gestation) with singleton gestation
- Proficient with English language
- Planning on undergoing scheduled cesarean delivery under neuraxial anesthesia
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Carbohydrate BeverageAlso: Preoperative beverageThe 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. | Dietary supplement | Oral Carbohydrate Beverage Group |
| Rehydration beverageAlso: Preoperative beverageThe 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. | Dietary supplement | Rehydration Beverage Group |
Primary outcome
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale.
Time frame: Change from baseline to one hour
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.
9 secondary outcomes
Changes between the maternal groups assessed by the mean arterial pressure (MAP) recordings in every 5 minute period
Time frame: At time of surgery to the conclusion
Number of participants admitted to maternal intensive care unit between the groups
Time frame: Up to 15 days
Number of days in the hospital for each participant between the groups
Time frame: Up to 15 days
Number of postoperative infections between the groups
Time frame: Up to 15 days
Neonates with plasma glucose level of less than 45 mg/dL between the groups
Time frame: Baseline
Number of neonates with a 5 minute Apgar score less than 7 between the groups
Time frame: 5 minutes
Number of neonates on ventilation for 6 hours or greater between the groups
Time frame: 6 hours
Number of neonates diagnosed with an infection between the groups.
Time frame: Baseline
Number of neonates admitted to the intensive care unit (ICU) between the groups
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Derived from this study: PubMed 32025843Wendling 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Wendling, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Carbohydrate Beverage and Rehydration beverage in people with Dehydration, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale. (time frame: Change from baseline to one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02684513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.