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Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Not Applicable
Conditions
Gastric Emptying
Pregnancy
Interventions
Dietary Supplement: Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml
Registration Number
NCT03800251
Lead Sponsor
Coombe Women and Infants University Hospital
Brief Summary

The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).

Detailed Description

Recent research suggests that attention to nutrition before operation leads to a speedier recovery through moderating the metabolic responses to surgery, improving well-being, decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy non-pregnant adults and consensus agreement.

The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml).

Patients who are fasting according to the current guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hours before their scheduled theatre time. Patients will then have their gastric volume assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested fluid to leave the stomach. The results of the study will give us more information regarding gastric emptying in the investigator's patient population and may lead to reduced fasting times, increasing patient comfort and improving the patient experience.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
40
Inclusion Criteria
  • Elective LSCS
  • 18yrs
  • gestation >38 gestation weeks
Exclusion Criteria
  • Multiple pregnancy
  • Previous upper GI surgery
  • Known disorder of gastric emptying
  • Hiatus Hernia
  • BMI >40
  • Diabetes Mellitus, Gestational Diabetes

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Fasting parturients at termNutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/mlFasting parturients at term, admitted for elective cesarean section, who consent to partake in the study
Primary Outcome Measures
NameTimeMethod
Time interval required to return to the fasting grade.2 hours

The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).

Secondary Outcome Measures
NameTimeMethod
Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section10 minutes

Initial "fasting" scan will be performed in all patients

Time taken for the antral cross sectional area (measured by ultrasound) to reach <9.6 cm2 (suggested cut off value for ingested volumes < 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink2 hours

Sequential ultrasound scans will be performed at 15 min intervals for 2 hours.

Antral cross sectional area at 2 hours2 hours

Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).

Trial Locations

Locations (1)

Coombe Women and Infants University Hospital

🇮🇪

Dublin, Ireland

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