Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Last updated: January 10, 2019
Sponsor: Coombe Women and Infants University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

N/A

Clinical Study ID

NCT03800251
8-2018
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Elective LSCS

  • 18yrs

  • gestation >38 gestation weeks

Exclusion

Exclusion Criteria:

  • Multiple pregnancy

  • Previous upper GI surgery

  • Known disorder of gastric emptying

  • Hiatus Hernia

  • BMI >40

  • Diabetes Mellitus, Gestational Diabetes

Study Design

Total Participants: 40
Study Start date:
June 06, 2018
Estimated Completion Date:
March 31, 2019

Study 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.

Connect with a study center

  • Coombe Women and Infants University Hospital

    Dublin, D08XW7X
    Ireland

    Active - Recruiting

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