PregnancyNCT03593980
Gastric Emptying Following an Oral Carbohydrate Load in Women Admitted for Elective Cesarean Delivery
A study testing Cranberry juice in people with Pregnancy and Respiratory Aspiration of Gastric Contents, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Because of the risk of pulmonary aspiration, patients are asked to comply with the fasting guidelines when they are scheduled for an elective cesarean section. This fasting can result in increased insulin resistance, and that this can delay patient recovery from surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Respiratory Aspiration of Gastric Contents
- What is being tested?
- Cranberry juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2018to 1 Jun 2020
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-laboring pregnant women ≥36 weeks gestational age, scheduled for cesarean delivery
- ≥18 years of age
- ASA physical status II to III
- weight 50 to 120 kg
- height ≥150 cm
- ability to understand the rationale of the study assessments.
Who cannot join
- Diabetes Mellitus
- patients who have not complied with fasting guidelines (8 hours of solid food or thick fluids, and no clear fluid 3 hours before the scheduled arrival time on Labor and Delivery for the study)
- abnormal anatomy of the upper gastrointestinal tract, and previous surgical procedures on the esophagus, stomach, or upper abdomen
- gastric ultrasound that is not compatible with empty stomach (gastric antrum grade 0 or 1 and CSA < 10.3 cm2 in the right lateral decubitus).
Trial locations and contacts
1 site in 1 country.
About this study
Because of the risk of pulmonary aspiration, patients are asked to comply with the fasting guidelines when they are scheduled for an elective cesarean section. This fasting can result in increased insulin resistance, and that this can delay patient recovery from surgery. Giving a patient a carbohydrate-rich beverage before surgery has been shown to reduce the post-operative insulin resistance and reduce the length of stay in the hospital.
In order to safely provide pregnant women with a carbohydrate-rich drink when admitted to the hospital in preparation for an elective cesarean delivery, the investigators must ensure that their stomach has emptied by the time they go to the operating room.
Read more
The objective is to investigate whether women admitted to the hospital, having complied with the fasting guidelines, will have an empty stomach 2 hours after being offered 400 ml of a beverage containing 50g of carbohydrate. This can easily be done with the use of an ultrasound exam of the stomach.
The hypothesis is that patients will have an empty stomach 2 hours after drinking 400 ml of a carbohydrate-rich beverage.
Read the detailed description
Fasting, even if for brief periods, results in a marked reduction in insulin sensitivity. This insulin resistance developed after surgery has been implicated in the increase of the length of stay at the hospital. Randomized studies involving either preoperative glucose infusion or ingestion of a carbohydrate-rich beverage have shown that postoperative insulin resistance may be reduced by about 50% when preoperative fasting is avoided.
One of the recommended methods to avoid the insulin resistance in the perioperative period is the provision of isotonic, carbohydrate-containing clear fluids up to 2 hours preoperatively, so that patients begin their surgery in a fed rather than fasted state. This has been called "carbohydrate loading". An amount of 50 g of carbohydrates is sufficient to produce an insulin response similar to that of a mixed solid meal.
Beverages containing different combinations of carbohydrate or protein have been used in different patient populations and support the safety of their use in the perioperative period. Although there is substantial evidence that gastric emptying is similar in non-laboring term pregnant women and non-pregnant it is unknown whether the maternal anxiety preceding the procedure and the addition of a 50 g carbohydrate containing beverage may cause delayed gastric emptying and increase the risk of aspiration in the obstetric population.
Bedside ultrasound assessment of the gastric content has shown good intra- and inter-rater reliability. Our group has previously demonstrated that in 103 women scheduled for elective cesarean, 95% of fasting subjects presented with an antral cross-sectional area ≤10.3 cm2.
In order to implement and to standardize a beverage containing 50 g of complex carbohydrate offered to women when admitted to the hospital in preparation for their elective cesarean delivery, the investigators must ensure that women have an empty stomach by the time they arrive to the operating room.
- Being tested
- Cranberry juice
- Keywords
- Gastric Ultrasound
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry juiceDietary supplement
400ml cranberry juice
| Study group | Role | What they receive |
|---|---|---|
| 400ml cranberry juice | Experimental | Patients will be given 400ml of cranberry juice to drink 3 hours prior to cesarean delivery. Receives: Dietary Supplement: Cranberry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral cross sectional area 2 hours
The antral cross sectional area will be measured using ultrasound at 2 hours after consumption of a 400ml beverage
Measured: 2 hours
Secondary outcomes (8)
Qualitative assessment of the antrum
The antrum will be viewed and graded (0-2, where 0=empty, 1=fluid and 2=solid/mixed meal content) at 5 minutes, 1 hour and 2 hours after consumption of a 400ml beverage
Measured: 2 hours
Antral cross sectional area at 5 min
The antral cross sectional area will be measured using ultrasound at 5 minutes after consumption of a 400ml beverage
Measured: 5 min
Antral cross sectional area at 1 hour
The antral cross sectional area will be measured using ultrasound at 1 hour after consumption of a 400ml beverage
Measured: 1hour
Patient satisfaction
Patient satisfaction will be assessed in the immediate postoperative period, on a Likert scale from 1-5 (1=strongly disagree and 5=strongly agree)
Measured: 2 hours
Intraoperative hypotension
Blood pressure during surgery measuring less than 80% of the patient's baseline
Measured: 1 hour
Presence of intraoperative pain
Pain will be self reported by the patient and treated by the physicians taking care of them.
Patients may be asked to rate their pain on a 0-10 scale (where 0 is no pain and 10 is the most terrible pain). Pain during surgery that requires opioid supplementation (at the discretion of the attending physician) will be considered.
Measured: 1 hour
Presence of intraoperative nausea: questionnaire (yes/no)
Patients will be asked to report any nausea during surgery. This will be recorded as 0=no presence of nausea, or 1=presence of nausea.
Measured: 1 hour
Presence of intraoperative vomiting: (yes/no)
Vomiting at any time during the surgery will be recorded (where 0=no vomiting, and 1=presence of vomiting).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start12 Sep 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Why it stopped: Study could not be run for logistical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593980
- Sponsor's protocol ID
- 18-06
- Status last verified
- Feb 2021
- First submitted
- 27 Jun 2018
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying Following an Oral Carbohydrate Load in Women Admitted for Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03593980
- Acronym / sponsor ID
- 18-06
- Keywords
- Gastric Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study could not be run for logistical reasons
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 20 Jul 2018 (actual)
- 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.
Because of the risk of pulmonary aspiration, patients are asked to comply with the fasting guidelines when they are scheduled for an elective cesarean section. This fasting can result in increased insulin resistance, and that this can delay patient recovery from surgery. Giving a patient a carbohydrate-rich beverage before surgery has been shown to reduce the post-operative insulin resistance and reduce the length of stay in the hospital.
In order to safely provide pregnant women with a carbohydrate-rich drink when admitted to the hospital in preparation for an elective cesarean delivery, the investigators must ensure that their stomach has emptied by the time they go to the operating room.
The objective is to investigate whether women admitted to the hospital, having complied with the fasting guidelines, will have an empty stomach 2 hours after being offered 400 ml of a beverage containing 50g of carbohydrate. This can easily be done with the use of an ultrasound exam of the stomach.
The hypothesis is that patients will have an empty stomach 2 hours after drinking 400 ml of a carbohydrate-rich beverage.
Detailed description
Fasting, even if for brief periods, results in a marked reduction in insulin sensitivity. This insulin resistance developed after surgery has been implicated in the increase of the length of stay at the hospital. Randomized studies involving either preoperative glucose infusion or ingestion of a carbohydrate-rich beverage have shown that postoperative insulin resistance may be reduced by about 50% when preoperative fasting is avoided.
One of the recommended methods to avoid the insulin resistance in the perioperative period is the provision of isotonic, carbohydrate-containing clear fluids up to 2 hours preoperatively, so that patients begin their surgery in a fed rather than fasted state. This has been called "carbohydrate loading". An amount of 50 g of carbohydrates is sufficient to produce an insulin response similar to that of a mixed solid meal.
Beverages containing different combinations of carbohydrate or protein have been used in different patient populations and support the safety of their use in the perioperative period. Although there is substantial evidence that gastric emptying is similar in non-laboring term pregnant women and non-pregnant it is unknown whether the maternal anxiety preceding the procedure and the addition of a 50 g carbohydrate containing beverage may cause delayed gastric emptying and increase the risk of aspiration in the obstetric population.
Bedside ultrasound assessment of the gastric content has shown good intra- and inter-rater reliability. Our group has previously demonstrated that in 103 women scheduled for elective cesarean, 95% of fasting subjects presented with an antral cross-sectional area ≤10.3 cm2.
In order to implement and to standardize a beverage containing 50 g of complex carbohydrate offered to women when admitted to the hospital in preparation for their elective cesarean delivery, the investigators must ensure that women have an empty stomach by the time they arrive to the operating room.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 400ml cranberry juice | Experimental | Dietary Supplement: Cranberry juicePatients will be given 400ml of cranberry juice to drink 3 hours prior to cesarean delivery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- non-laboring pregnant women ≥36 weeks gestational age, scheduled for cesarean delivery
- ≥18 years of age
- ASA physical status II to III
- weight 50 to 120 kg
- height ≥150 cm
Key exclusion criteria (4 listed)
- Diabetes Mellitus
- patients who have not complied with fasting guidelines (8 hours of solid food or thick fluids, and no clear fluid 3 hours before the scheduled arrival time on Labor and Delivery for the study)
- abnormal anatomy of the upper gastrointestinal tract, and previous surgical procedures on the esophagus, stomach, or upper abdomen
- gastric ultrasound that is not compatible with empty stomach (gastric antrum grade 0 or 1 and CSA < 10.3 cm2 in the right lateral decubitus).
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 |
|---|---|---|
| Cranberry juice400ml cranberry juice | Dietary supplement | 400ml cranberry juice |
Primary outcome
Antral cross sectional area 2 hours
Time frame: 2 hours
The antral cross sectional area will be measured using ultrasound at 2 hours after consumption of a 400ml beverage
8 secondary outcomes
Qualitative assessment of the antrum
Time frame: 2 hours
Antral cross sectional area at 5 min
Time frame: 5 min
Antral cross sectional area at 1 hour
Time frame: 1hour
Patient satisfaction
Time frame: 2 hours
Intraoperative hypotension
Time frame: 1 hour
Presence of intraoperative pain
Time frame: 1 hour
Presence of intraoperative nausea: questionnaire (yes/no)
Time frame: 1 hour
Presence of intraoperative vomiting: (yes/no)
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Study could not be run for logistical reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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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.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry juice in people with Pregnancy and Respiratory Aspiration of Gastric Contents, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Mar 2021. 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 Canada. 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 was stopped early (reason given: Study could not be run for logistical reasons). Results are not available in the source record.
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?
Antral cross sectional area 2 hours (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2021.