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Gastric EmptyingNCT07407530

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

A study testing The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink and The "water group" in people with Gastric Emptying and Caesarean Delivery, run by The Rotunda Hospital at 2 sites in Ireland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gastric Emptying, Caesarean Delivery, Pregnancy
What is being tested?
The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink and The "water group"
Could I receive a placebo?
No, everyone receives an active treatment
How many people
190 participants
Where
2 sitesIreland
Study dates
1 Aug 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Age <18 years
  • Insulin dependent diabetes mellitus (type 1 or 2)
  • Gestational diabetes

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan Howle, Consultant anaesthesiologist contact

0830851686 ext. +353

rhowle@rotunda.ie

Ireland2 sites, 2 recruiting
  • Rotunda Hospital

    Dublin, Ireland/County Dublin, D01P5W9

    Ryan Howle, Consultant anesthesiologist, (01)8171700 ext. +353, rhowle@rotunda.ie

    Francesco Vernace, NCHD Anaesthesiologist

    Not yet recruiting
  • Rotunda Hospital

    Dublin, D01 P5W9

    Recruiting

Other trials in Ireland

About this study

Official title: Comparison of 'Sip Til Send' Regimens Prior to Elective Caesarean Delivery Using Bedside Gastric Ultrasound: a Randomized Study Comparing Water With Carbohydrate-rich Drink

'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.

Read the detailed description

This study is a prospective randomized single-blinded study. Randomisation 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.

This study will incorporate clinical practice protocols that are already in place at the Rotunda hospital. The enhanced recovery guidelines encourage consumption of carbohydrate drinks prior to arrival at hospital for surgery. This protocol was superseded by the introduction of 'Sip Til Send' with water with an aim to reduce fasting times after arrival at hospital, but adherence with both practices is variable.

The study intervention is the provision of water or a standard carbohydrate-rich drink which the participants may sip to comfort 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. The carbohydrate group represent the interventional group and will utilise the same carbohydrate drinks available for enhanced recovery.

Eligible participants booked to undergo an elective CD will be recruited on the day of surgery by a member of the research team. Consideration will depend on the research team availability, expected fasting time of more than 1 hour and full adherence of European fasting guidelines at the time of study entry (6 hours for solids and 2 hours for liquids). Following recruitment, written consent is obtained and a 'fasting' gastric ultrasound will be performed in a standardised manner prior to randomisation. If a Perlas grade 2 antrum is encountered, this will be assumed to represent a full stomach (>1.5ml/kg) and the potential participant be removed from the study. To mitigate any further risk, they will be advised to fully fast, not be offered 'Sip Til Send' and the anaesthesiologist in charge of their clinical care will be informed. Any women in whom adequate views of the gastric antrum cannot be obtained in both positions will also be removed from the study. All other participants will then be randomized into the study.

Following group allocation, women will be provided with a weighed jug of water or carbohydrate drink, a 170ml cup and written instructions stating that they may drink continually to comfort up to 1 cup and hour and information on how to refill if required. Prior to their CD, any remaining drink will be weighed to calculate to volume consumed (assuming a liquid density of 1mg/ml) and participants will undergo a second gastric ultrasound scan immediately prior to surgery.

Normal clinical care will resume after this point with group allocation having no impact on care received. During surgery, a urine sample will be collected via the catheter bag following written consent and will be sent to the hospital laboratory to test for ketones. This result will also be available to the treating clinicians.

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). Following discharge from hospital, medical notes will be interrogated for evidence of perioperative nausea, vomiting or aspiration and neonatal notes will also be interrogated for evidence of treated hypoglycaemia.

Gastric ultrasound is a safe non-invasive scan which will take about 10 minutes to complete. It involves placement of a curvilinear ultrasound probe on the upper abdomen whilst the participant is on their back and then their right-hand side. The head of the bed will be elevated to 45 degrees during the scan for comfort and to prevent aortocaval compression. A qualitative Perlas score is given based on whether clear liquid is seen in the antrum in each position. A Perlas 0 antrum has no fluid in either position, a Perlas 1 has clear fluid in the right-lateral position but not when semi-recumbent and a Perlas 2 score has identifiable clear fluid in both positions. Gastric antrum CSA will be calculated using horizontal and vertical calliper measurements inputted into a formula to calculate the area of an ellipse. These will also be used to estimate gastric volumes via the method below that has been validated in term pregnant women previously:

GV (mL) = 0.18 x right-lateral CSA (mm2) + 0.11 x semirecumbent CSA (mm2) - 62.4

Being tested
The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink, The "water group"
Keywords
gastric ultrasound, gastric emptying, cesarean section, pregnancy, fasting guidelines

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drinkDrug

    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)

  • 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

Study groups in NCT07407530
Study groupRoleWhat they receive
'Sip Til Send' with waterOtherThe "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.
Receives: Drug: The "water group"
'Sip Til Send' with carbohydrate-rich drinksActive comparatorthe "carbohydrate" group will be encouraged to sip a standardised carbohydrate-rich drink ,flavoured clear, carbohydrate drink " Nutricia preOp".
Receives: Drug: The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: From enrollment until just before their cesarean delivery.

Secondary outcomes (6)
  1. Estimated residual gastric volume before CD

    Compare the estimated residual gastric volumes prior to caesarean delivery : Gastric antrum CSA will be calculated using horizontal and vertical calliper measurements inputted into a formula to calculate the area of an ellipse. These will also be used to estimate gastric volumes via the method below that has been validated in term pregnant women previously:

    GV (mL) = 0.18 x right-lateral CSA (mm2) + 0.11 x semirecumbent CSA (mm2) - 62.4

    Measured: From enrollment until just before their cesarean delivery.

  2. Incidence of a full stomach assessed by quantitative ultrasound measurements

    Compare the incidence of estimated residual gastric volumes >1.5ml/kg

    Measured: From enrollment until just before their cesarean delivery.

  3. Qualitative ultrasound guided incidence of a full stomach

    Compare the incidence of Perlas 2 scores : A qualitative Perlas score is given based on whether clear liquid is seen in the antrum in each position. A Perlas 0 antrum has no fluid in either position, a Perlas 1 has clear fluid in the right-lateral position but not when semi-recumbent and a Perlas 2 score has identifiable clear fluid in both positions

    Measured: From enrollment until just before their cesarean delivery.

  4. Compare the maternal urinary ketones during caesarean delivery

    During surgery, a urinary catheter is inserted as part of standard clinical care. A urine sample will be collected from this prior to delivery and sent to the lab to test for ketones.

    Measured: From enrollment until just before their cesarean delivery.

  5. Gastric antrums CSA Vs Estimated gastric volumes

    Compare the average difference in gastric antrum CSA and estimated gastric volume over the course of 'Sip Til Send'

    Measured: From enrollment until just before their cesarean delivery.

  6. Incidence of treated neonatal hypoglycaemia

    Compare the incidence of treated hypoglycaemia in the neonates: following discharge from hospital, medical neonatal notes will be interrogated for evidence of treated hypoglycaemia

    Measured: Immediately after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start1 Aug 2025
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
190 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07407530
Sponsor's protocol ID
REC2025-005
Status last verified
Feb 2026
First submitted
17 Jul 2025
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink and The "water group" in people with Gastric Emptying and Caesarean Delivery, run by The Rotunda Hospital at 2 sites in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryan Howle, Consultant anaesthesiologist (0830851686 ext. +353, rhowle@rotunda.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour Obstetric Quality of Recovery-10 (ObsQoR-10) scores (time frame: From enrollment to around 24 hours after delivery (+/- 4 hours).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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