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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03593980
• Other study ID #: 18-06
• Status: Terminated
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: February 2021
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pregnancy
• Respiratory Aspiration
• Respiratory Aspiration of Gastric Contents

Intervention

Dietary Supplement:
• Cranberry juice
400ml cranberry juice

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 hours
Secondary	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	2 hours
Secondary	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	5 min
Secondary	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	1hour
Secondary	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)	2 hours
Secondary	Intraoperative hypotension	Blood pressure during surgery measuring less than 80% of the patient's baseline	1 hour
Secondary	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.	1 hour
Secondary	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.	1 hour
Secondary	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).	1 hour