Elective Cesarean DeliveryNCT06505915
Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send'
A study testing Pre op Carbohydrate drink and Clear fluid as per sip til send policy in people with Elective Cesarean Delivery and Fasting ( 6H for Solid ; 2H for Clear Fluid ), run by The Rotunda Hospital at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Elective Cesarean Delivery, Fasting ( 6H for Solid ; 2H for Clear Fluid )
- What is being tested?
- Pre op Carbohydrate drink and Clear fluid as per sip til send policy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 12 Feb 2024to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send': A Randomised Trial of Two Different Fasting Protocols at Elective Caesarean Delivery
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.
Read the detailed description
This is a study focused on comparing fasting policies that are in use at the Rotunda.
Investigators wish to determine the best fasting policy for women at elective caesarean delivery by focusing on assessing outcomes related to the patient experience.
A 'Sip til send' fasting policy means women may drink clear fluid up until the time they are called from the ward to come to theatre for their elective caesarean delivery. This policy was implemented at the Rotunda in 2022 and was studied prospectively, investigators demonstrated improvements in the comfort that women experience in their perioperative journey, compared to a traditional fasting protocol where women must fast for many hours for both fluids and solids before they come to theatre.
It has been shown that oral carbohydrate intake may improve outcomes in general and cardiac surgeries, but there is very limited evidence in obstetrics. The Rotunda is increasingly providing women with carbohydrate drinks prior to CD. These drinks are consumed by the patient on the morning of surgery as part of an enhanced recovery after surgery (ERAS) package. There is little evidence to support the use of carbohydrate drinks, but current thinking is that they may increase energy and comfort and reduce metabolic changes due to prolonged fasting.
Pregnant women are more vulnerable to the side effects related to the extended fasting due to the accelerated fasting in the third trimester of pregnancy after an overnight fast pre-operatively. Carbohydrate reserves are rapidly exhausted, causing hypoglycemia, increased urine nitrogen secretion (indicating muscle catabolism), and increased urinary ketone body concentration. It has been recommended that Mothers in their third trimester avoid skipping meals.
Investigators wish to study the effects of integrating carbohydrate drinks into the current 'sip til send' fasting protocol and determine if these women benefit from either protocol.
- Being tested
- Pre op Carbohydrate drink, Clear fluid as per sip til send policy
- Keywords
- cesarean section and fasting protocols
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre op Carbohydrate drinkDietary supplement
Lemon flavoured clear carbohydrate drink
Clear fluid as per sip til send policyOther
clear fluid such as water
| Study group | Role | What they receive |
|---|---|---|
| Group C | Experimental | fasting protocol consuming carbohydrate drinks before elective caesarean delivery and sipping water until called to theatre Receives: 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 Receives: Other: Clear fluid as per sip til send policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately Preoperatively
Secondary outcomes (1)
General well-being of the patient
- Intraoperative nausea and vomiting: Assessed as YES or NO
- Pre-operative urinary ketone level: Assessed with urine dipstick showing POSITIVE or NEGATIVE
- Pre-operative blood sugar level: Measured on glucometer in mmol/lt
- Quality of recovery score following ceaserean delivery (ObsQoR11) score at 24 hours: consists of 11 questions related to how the symptoms have been in the last 24 hours regarding pain, vomiting, dizziness, shivering, comfort level, mobility, and the requirement of assistance related to looking after one's self and the baby. Each aspect is measured from a scale of 0 to 10, 0 being minimal and 10 being maximum.
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start12 Feb 2024
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Rotunda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Muhammad Shoaib Sadiq, The Rotunda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505915
- Sponsor's protocol ID
- REC-2023-026
- Status last verified
- Apr 2025
- First submitted
- 30 Jun 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41087945
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send': A Randomised Trial of Two Different Fasting Protocols at Elective Caesarean Delivery
- ClinicalTrials.gov ID
- NCT06505915
- Acronym / sponsor ID
- REC-2023-026
- Keywords
- cesarean section and fasting protocols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Rotunda HospitalUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a study focused on comparing fasting policies that are in use at the Rotunda.
Investigators wish to determine the best fasting policy for women at elective caesarean delivery by focusing on assessing outcomes related to the patient experience.
A 'Sip til send' fasting policy means women may drink clear fluid up until the time they are called from the ward to come to theatre for their elective caesarean delivery. This policy was implemented at the Rotunda in 2022 and was studied prospectively, investigators demonstrated improvements in the comfort that women experience in their perioperative journey, compared to a traditional fasting protocol where women must fast for many hours for both fluids and solids before they come to theatre.
It has been shown that oral carbohydrate intake may improve outcomes in general and cardiac surgeries, but there is very limited evidence in obstetrics. The Rotunda is increasingly providing women with carbohydrate drinks prior to CD. These drinks are consumed by the patient on the morning of surgery as part of an enhanced recovery after surgery (ERAS) package. There is little evidence to support the use of carbohydrate drinks, but current thinking is that they may increase energy and comfort and reduce metabolic changes due to prolonged fasting.
Pregnant women are more vulnerable to the side effects related to the extended fasting due to the accelerated fasting in the third trimester of pregnancy after an overnight fast pre-operatively. Carbohydrate reserves are rapidly exhausted, causing hypoglycemia, increased urine nitrogen secretion (indicating muscle catabolism), and increased urinary ketone body concentration. It has been recommended that Mothers in their third trimester avoid skipping meals.
Investigators wish to study the effects of integrating carbohydrate drinks into the current 'sip til send' fasting protocol and determine if these women benefit from either protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Experimental | Dietary Supplement: Pre op Carbohydrate drinkfasting protocol consuming carbohydrate drinks before elective caesarean delivery and sipping water until called to theatre |
| Group S | Active comparator | Other: Clear fluid as per sip til send policyfasting protocol NOT consuming carbohydrate drinks before elective caesarean delivery, but encouraged to sip water until called to theatre |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre op Carbohydrate drinkLemon flavoured clear carbohydrate drink | Dietary supplement | Group C |
| Clear fluid as per sip til send policyclear fluid such as water | Other | Group S |
Primary outcome
General well-being of the patient
Time frame: Immediately Preoperatively
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
1 secondary outcome
General well-being of the patient
Time frame: 24 hours post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Derived from this study: PubMed 41087945Sadiq 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre op Carbohydrate drink and Clear fluid as per sip til send policy in people with Elective Cesarean Delivery and Fasting ( 6H for Solid ; 2H for Clear Fluid ), run by The Rotunda Hospital at 1 site 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 7 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: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General well-being of the patient (time frame: Immediately Preoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06505915, which also lists 1 linked publication.
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 4 Apr 2025.