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

NCT03593980 | Terminated

• 1 other identifier: 18-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Respiratory Aspiration of Gastric Contents

Keywords

Gastric Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Qualitative assessment of the antrum

  2 hours

• Antral cross sectional area at 5 min

  5 min

• Antral cross sectional area at 1 hour

  1hour

• Patient satisfaction

  2 hours

• Intraoperative hypotension

  1 hour

Study Arms (1)

400ml cranberry juice

EXPERIMENTAL

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

Dietary Supplement: Cranberry juice

Interventions

Cranberry juice DIETARY_SUPPLEMENT

400ml cranberry juice

400ml cranberry juice

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M9W2S4, Canada

Location

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 20, 2018
• Study Start: September 12, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

CA (1)