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Gastric Emptying Following an Oral Carbohydrate Load in Women Admitted for Elective Cesarean Delivery

Primary Purpose

Pregnancy, Respiratory Aspiration of Gastric Contents

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cranberry juice
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Gastric Ultrasound

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

400ml cranberry juice

Arm Description

Patients will be given 400ml of cranberry juice to drink 3 hours prior to cesarean delivery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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)
Intraoperative hypotension
Blood pressure during surgery measuring less than 80% of the patient's baseline
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.
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.
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).

Full Information

First Posted
June 27, 2018
Last Updated
February 26, 2021
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03593980
Brief Title
Gastric Emptying Following an Oral Carbohydrate Load in Women Admitted for Elective Cesarean Delivery
Official Title
Gastric Emptying Following an Oral Carbohydrate Load in Women Admitted for Elective Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Study could not be run for logistical reasons
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Respiratory Aspiration of Gastric Contents
Keywords
Gastric Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400ml cranberry juice
Arm Type
Experimental
Arm Description
Patients will be given 400ml of cranberry juice to drink 3 hours prior to cesarean delivery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry juice
Intervention Description
400ml cranberry juice
Primary Outcome Measure Information:
Title
Antral cross sectional area 2 hours
Description
The antral cross sectional area will be measured using ultrasound at 2 hours after consumption of a 400ml beverage
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Qualitative assessment of the antrum
Description
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
Time Frame
2 hours
Title
Antral cross sectional area at 5 min
Description
The antral cross sectional area will be measured using ultrasound at 5 minutes after consumption of a 400ml beverage
Time Frame
5 min
Title
Antral cross sectional area at 1 hour
Description
The antral cross sectional area will be measured using ultrasound at 1 hour after consumption of a 400ml beverage
Time Frame
1hour
Title
Patient satisfaction
Description
Patient satisfaction will be assessed in the immediate postoperative period, on a Likert scale from 1-5 (1=strongly disagree and 5=strongly agree)
Time Frame
2 hours
Title
Intraoperative hypotension
Description
Blood pressure during surgery measuring less than 80% of the patient's baseline
Time Frame
1 hour
Title
Presence of intraoperative pain
Description
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.
Time Frame
1 hour
Title
Presence of intraoperative nausea: questionnaire (yes/no)
Description
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.
Time Frame
1 hour
Title
Presence of intraoperative vomiting: (yes/no)
Description
Vomiting at any time during the surgery will be recorded (where 0=no vomiting, and 1=presence of vomiting).
Time Frame
1 hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose CA Carvalho, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W2S4
Country
Canada

12. IPD Sharing Statement

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Gastric Emptying Following an Oral Carbohydrate Load in Women Admitted for Elective Cesarean Delivery

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