Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send'

NCT06505915 | Completed

• 1 other identifier: REC-2023-026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Women undergoing elective caesarean deliveries are fasted for long periods prior to surgery. Recently, Rotunda Maternity Hospital have started using two fasting protocols at the Rotunda prior to elective caesarean section, one uses carbohydrate drinks, and the other encourages women to sip water until they are called to the operating theatre. The evidence to support the use of either one is very limited. This study would help streamline one of the protocols.

Conditions

Elective Cesarean Delivery; Fasting ( 6H for Solid ; 2H for Clear Fluid )

Keywords

cesarean section and fasting protocols

Outcome Measures

Primary Outcomes (1)

• General well-being of the patient

  Compare fasting protocols using a 0-10 Visual Analogue Score (VAS) for patient-focused comfort outcomes, including anxiety, thirst, hunger, nausea, and comfort. Each of them would be scored from 0 to 10, 0 being nothing and 10 being the maximum score relative to the feeling

  Immediately Preoperatively

Secondary Outcomes (1)

• General well-being of the patient

  24 hours post operative

Study Arms (2)

Group C

EXPERIMENTAL

fasting protocol consuming carbohydrate drinks before elective caesarean delivery and sipping water until called to theatre

Dietary Supplement: Pre op Carbohydrate drink

Group S

ACTIVE COMPARATOR

fasting protocol NOT consuming carbohydrate drinks before elective caesarean delivery, but encouraged to sip water until called to theatre

Other: Clear fluid as per sip til send policy

Interventions

Pre op Carbohydrate drink DIETARY_SUPPLEMENT

Lemon flavoured clear carbohydrate drink

Group C

Clear fluid as per sip til send policy OTHER

clear fluid such as water

Group S

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All pregnant patients coming in for elective caesarean sections
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective caesarean section for singleton pregnancy under neuraxial anaesthesia.
• Subjects able to give informed consent and willing to comply with the study protocol.
• Subjects must be greater than 18 years old

You may not qualify if:

• Diabetes Mellitus - including gestational diabetes.
• Known foetal abnormality.
• Planned general anaesthesia.
• Elective caesarean delivery at a gestation of less than 37 weeks.
• Low birth weight 2.5 kg (IUGR)
• BMI greater than 45 kg/m2
• Women with severe gastro-oesophageal reflux disease

Sponsors & Collaborators

• The Rotunda Hospital: lead

Study Sites (1)

Rotunda Maternity Hospital

Dublin, Dublin, Ireland

Location

Related Publications (1)

• Sadiq RS, Murphy C, Drew T. A carbohydrate loading fasting protocol versus 'Sip til Send': a randomised trial of two different fasting protocols at elective caesarean delivery. BMC Anesthesiol. 2025 Oct 14;25(1):495. doi: 10.1186/s12871-025-03340-3.

  PMID: 41087945 DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesia Fellow

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 17, 2024
• Study Start: February 12, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

IE (1)