An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using Beside Gastric Ultrasound

August 1, 2023 updated by: Ryan Howle, Coombe Women and Infants University Hospital

An Evaluation of a Liberal Hydration Regimen Before Elective Caesarean Section Using

The aim of this study is to compare the residual gastric volumes in non-labouring parturients prior to elective Caesarean delivery when fully fasted as per European Society of Anaesthesia pre-operative fasting guidelines against the 'Sip Til Send' fasting guideline via a paired cohort study. The primary hypothesis is that 'Sip Til Send' would be non-inferior to standard fasting at minimising the residual gastric volume prior to surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

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

Study Locations

  • Ireland
      • Dublin, Ireland
        • Coombe Women's Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

women who are undergoing a planned elective caesarean delivery

Description

Inclusion Criteria:

  • planned caesarean delivery under regional anaesthesia
  • adhered to national fasting guidance of 6 hrs for food and 2 hours for clear fluids

Exclusion Criteria:

  • age less than 18
  • inability to understand English

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric volume
Time Frame: 3 months
whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section.
3 months

Collaborators and Investigators

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

Sponsor

Coombe Women and Infants University Hospital

Investigators

  • Principal Investigator: Ryan Howle, Coombe Womens 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)

March 13, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUS123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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