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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05783427
Other study ID # GUS123
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2023
Est. completion date June 1, 2023

Study information

Verified date August 2023
Source Coombe Women and Infants University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Aspiration; Gastric Contents, Anesthesia
  • Respiratory Aspiration of Gastric Contents

Intervention

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

Locations

Country Name City State
Ireland Coombe Women's Hospital Dublin

Sponsors (1)

Lead Sponsor Collaborator
Coombe Women and Infants University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary gastric volume whether a liberal hydration protocol can be safely provided to pregnant women undergoing elective caesarean section. 3 months
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