NCT05783427

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

March 13, 2023

Last Update Submit

August 1, 2023

Conditions

Aspiration; Gastric Contents, Anesthesia

Outcome Measures

Primary Outcomes (1)

  • gastric volume

    whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section.

    3 months

Interventions

liberal hydrationOTHER

evaluate the effect of 'Sip Til Send' on overall gastric volume pregnant women undergoing elective caesarean delivery

Also known as: 'sip til send'

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women who are undergoing a planned elective caesarean delivery

You may qualify if:

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

You may not qualify if:

  • age less than 18
  • inability to understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coombe Women's Hospital

Dublin, Ireland

Location

Related Publications (1)

  • Harnett C, Connors J, Kelly S, Tan T, Howle R. Evaluation of the 'Sip Til Send' regimen before elective caesarean delivery using bedside gastric ultrasound: A paired cohort pragmatic study. Eur J Anaesthesiol. 2024 Feb 1;41(2):129-135. doi: 10.1097/EJA.0000000000001926. Epub 2023 Nov 20.

    PMID: 37982593DERIVED

Study Officials

  • Ryan Howle

    Coombe Womens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Consultant Anaesthesiologist

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

March 13, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

IE(1)