Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section

January 10, 2019 updated by: Petar Popivanov, Coombe Women and Infants University Hospital
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ireland
      • Dublin, Ireland, D08XW7X
        • Recruiting
        • Coombe Women and Infants University Hospital
        • Contact:
        • Principal Investigator:
          • Michelle Walsh, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fasting parturients at term
Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study
Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time interval required to return to the fasting grade.
Time Frame: 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).
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section
Time Frame: 10 minutes
Initial "fasting" scan will be performed in all patients
10 minutes
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 drink
Time Frame: 2 hours
Sequential ultrasound scans will be performed at 15 min intervals for 2 hours.
2 hours
Antral cross sectional area at 2 hours
Time Frame: 2 hours
Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coombe Women and Infants University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

At the moment there is no plan whether or not to make the IPD available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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