Comparison of 'Sip Til Send' Regimens Prior to Elective Caesarean Delivery Using Bedside Gastric Ultrasound

NCT07407530 | Recruiting

• 1 other identifier: REC2025-005
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief Summary

'Sip Til send' is a liberal drinking policy that replaces fasting before a caesarean delivery, meaning that women waiting in hospital can freely drink sips of water until they are called from the ward for their delivery. Studies has shown that 'Sip Til send' is safe and it improves the experience around surgery. Separate from this, drinking carbohydrate-rich drinks at specified time intervals before surgery is also recommended by international guidelines as part of a package of care aimed at enhancing recovery from surgery, and studies demonstrate that carbohydrate drinks significantly lower hunger sensation before caesarean delivery. The aim of this study is to combine these two interventions and compare the effects of sipping water against sipping carbohydrate drinks whilst waiting for a caesarean delivery and look at the stomach contents before delivery to ensure it is a safe practice and look at how women rate the quality of their recovery to see which practice is preferred. We will recruit women due to have an elective caesarean delivery whilst awake with a spinal anaesthetic at the Rotunda Hospital and only include those who are fully fasted on their arrival and would be candidates for the current 'Sip Til Send' policy. They will then be assigned to one of two groups, the "water" group who will be encouraged to sip water whilst waiting for surgery, and the "carbohydrate" group who will be encouraged to sip a standardised carbohydrate-rich drink instead. Using a bedside ultrasound machine, we will image the stomach and estimate the volume of liquid contents on two occasions; first, following recruitment to the study when fully fasted and before starting 'Sip Til Send', and second is immediately prior to surgery. Fluid intake will be closely monitored, and all participants will be asked to complete a short questionnaire the day after their delivery that asks them to rate aspects of their recovery. Participants and their newborns will not undergo any additional invasive testing for the study. Participants and their newborns will not undergo any additional invasive testing for the study, but consent will be sought to test women's urine for ketones (collected from the catheter bag during surgery). Medical notes will also be looked at after discharge to identify adverse outcomes such as nausea or vomiting during surgery and low blood sugar in the newborn. The study should run for approximately 3 to 6 months.

Conditions

Gastric Emptying; Caesarean Delivery; Pregnancy

Keywords

gastric ultrasound; gastric emptying; cesarean section; pregnancy; fasting guidelines

Outcome Measures

Primary Outcomes (2)

• 24-hour Obstetric Quality of Recovery-10 (ObsQoR-10) scores

  Compare the 24-hour quality of recovery scores : At around 24 hours after delivery (+/- 4 hours), women will be approached for a single follow-up visit where they will be asked to complete an obstetric-specific quality of recovery score (ObsQoR-10). This is scale from 0 to 100, with a higher number indicating a better quality of recovery.

  From enrollment to around 24 hours after delivery (+/- 4 hours).

• Gastric antrum CSA

  Compare the gastric antrum CSA immediately prior to caesarean delivery: 'fasting' gastric ultrasound will be performed in a standardised manner prior to randomization, Prior to their CD, participants will undergo a second gastric ultrasound scan immediately prior to surgery.

  From enrollment until just before their cesarean delivery.

Secondary Outcomes (6)

• Estimated residual gastric volume before CD

  From enrollment until just before their cesarean delivery.

• Incidence of a full stomach assessed by quantitative ultrasound measurements

  From enrollment until just before their cesarean delivery.

• Qualitative ultrasound guided incidence of a full stomach

  From enrollment until just before their cesarean delivery.

• Compare the maternal urinary ketones during caesarean delivery

  From enrollment until just before their cesarean delivery.

• Gastric antrums CSA Vs Estimated gastric volumes

  From enrollment until just before their cesarean delivery.

Study Arms (2)

'Sip Til Send' with water

OTHER

The "water" group who will be encouraged to sip at a maximum rate of 1 cup (170ml) per hour whilst waiting in hospital for an elective CD planned under neuraxial anaesthesia. The water group represent the control or standard practice group as this is in line with current hospital policy.

Drug: The "water group"

'Sip Til Send' with carbohydrate-rich drinks

ACTIVE COMPARATOR

the "carbohydrate" group will be encouraged to sip a standardised carbohydrate-rich drink ,flavoured clear, carbohydrate drink " Nutricia preOp".

Drug: The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink

Interventions

The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink DRUG

the "carbohydrate" group will be encouraged to sip a standardised carbohydrate-rich drink at a maximum rate of 1 cup (170ml) per hour, whilst waiting in hospital for an elective CD planned under neuraxial anaesthesia. Prior to their CD, any remaining drink will be weighed to calculate to volume consumed (assuming a liquid density of 1mg/ml)

'Sip Til Send' with carbohydrate-rich drinks

The "water group" DRUG

women will be provided with a weighed jug of water which the participants may sip to comfort at a maximum rate of 1 cup (170ml) per hour

'Sip Til Send' with water

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned caesarean delivery under regional anaesthesia
• Adhered to national fasting guidance of 6 hours for food and 2 hours for clear fluids
• Eligible for Sip Til Send

You may not qualify if:

• Planned general anaesthesia
• Emergency or urgent caesarean delivery
• Not fasted at time of recruitment
• Unable to visualise stomach or Perlas 2 stomach identified at time of recruitment
• Obesity of BMI \>40
• Previous upper GI or bariatric surgery
• Age \<18 years
• Insulin dependent diabetes mellitus (type 1 or 2)
• Gestational diabetes

Sponsors & Collaborators

• The Rotunda Hospital: lead

Study Sites (2)

Rotunda Hospital

Dublin, Ireland/County Dublin, D01P5W9, Ireland

NOT YET RECRUITING

Rotunda Hospital

Dublin, D01 P5W9, Ireland

RECRUITING

Central Study Contacts

Ryan Howle, Consultant anaesthesiologist

CONTACT

0830851686; rhowle@rotunda.ie

Study Design

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

Model Details: Prospective randomized single-blinded study. Randomization to intervention which will be "water" group and "carbohydrate" group. Pregnant women cannot be blinded to the intervention, but the healthcare workers and the investigators will be blinded to the intervention

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: February 12, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

IE (2)