Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2019-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Gastric Emptying Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fasting parturients at term

Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study

Group Type OTHER

Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml

Intervention Type DIETARY_SUPPLEMENT

Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink

Interventions

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Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml

Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes