FastingNCT04159948
Preoperative Carbohydrate Drink Prior to Elective Caesarean Section
A study testing Carbohydrate drink in people with Fasting and Cesarean Delivery Affecting Fetus, run by Coombe Women and Infants University Hospital at 1 site in Ireland.
Trial summary
Prior to caesarean section, patients should fast from solid food for 6 hours and from clear fluids for 2 hours. Carbohydrate drinks can also be consumed up to 2 hours before surgery. 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
- Fasting, Cesarean Delivery Affecting Fetus, Glucose, Low Blood
- What is being tested?
- Carbohydrate drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteIreland
- Study dates
- 20 Jan 2020to 10 Aug 2021
- 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.
- General anaesthesia.
- Gestation < 37 weeks.
- Steroids received within 4 days of delivery.
- Low birth weight 2.5 kg (IUGR)
- BMI > 40 kg/m2
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Coombe Women and Infants University Hospital
Dublin
Ruairi Irwin, 014085200
About this study
Official title: Preoperative Carbohydrate Drink Prior to Elective Caesarean Section: A Randomized Controlled Trial.
Prior to caesarean section, patients should fast from solid food for 6 hours and from clear fluids for 2 hours. Carbohydrate drinks can also be consumed up to 2 hours before surgery. These drinks have been shown to improve patient well-being after surgery and may potentially improve the neonatal blood glucose level after delivery and reduce the risk of a low blood glucose level. This study aims to assess the influence of pre-operative carbohydrate drinks on blood glucose levels of the baby at delivery.
Read the detailed description
Patients recruited to the study will be randomised to one of 3 groups.
Group 1 will receive standard care as per our current practice. This includes fasting from solids for 6 hours prior to surgery and clear fluids for up to 2 hours prior to surgery.
Group 2 will receive a carbohydrate (CHO) drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this CHO drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Group 3 will receive an apple juice drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this apple juice drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Before the start of surgery, the patients non-dominant hand grip strength will be assessed using the dynamometer. Their subjective sense of thirst and hunger will be assessed. Their fasting times for food and fluids will be recorded. The patients' blood glucose will be measured from a blood sample as their intravenous cannula is inserted. The maternal urinary ketones will be measured from a urine sample upon insertion.
The neonatal blood cord glucose will be measured from both an arterial and venous cord blood sample after delivery. This will be performed by the trained anaesthesia research fellow. Should hypoglycemia be identified, the hospital's neonatal hypoglycemia algorithm will be followed appropriately.
The patients will be followed up at 24 hours by an outcome assessor blinded to the group allocation. Numerical rating scale (NRS) pain scores, postoperative nausea and vomiting and quality of recovery will be assessed at the patients beside. All neonates will be followed up to calculate admissions to neonatal unit and the number of glucose sachets required for hypoglycemia.
- Being tested
- Carbohydrate drink
- Keywords
- Carbodydrate drink
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkDietary supplement
This is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes.
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Patients will be allowed to drink water up to 2 hours before their caesarean section. Receives: Dietary Supplement: Carbohydrate drink |
| Carbohydrate drink | Active comparator | Patients will be allowed to drink a designated carbohydrate drink up to 2 hours before their caesarean section. Receives: Dietary Supplement: Carbohydrate drink |
| Apple juice | Active comparator | Patients will be allowed to drink apple juice up to 2 hours before their caesarean section. Receives: Dietary Supplement: Carbohydrate drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal cord blood glucose
A blood sample of the neonatal cord will be checked immediately after delivery.
Measured: 0 hours
Secondary outcomes (14)
Neonate tolerating 1st oral feeding.
Binary outcome - Neonate consuming adequate breast or bottle milk.
Measured: 0-2 hours
Number of neonatal rescue oral glucose sachets given.
Continuous - Number of neonatal rescue oral glucose sachets given.
Measured: 6 hours
Neonate requiring ICU admission and treatment for hypoglycemia
Binary - Neonate requiring ICU admission and treatment for hypoglycemia
Measured: 6 hours
Maternal blood glucose
Maternal blood glucose prior to the start of caesarean section.
Measured: 0 hours
Maternal urinary ketones
Maternal urinary ketones prior to the start of caesarean section.
Measured: 0 hours
Maternal subjective sense of thirst prior to the start of caesarean section.
Scored on a scale 0-10
Measured: 0 hours
Maternal subjective sense of hunger prior to the start of caesarean section.
Scored on a scale 0-10
Measured: 0 hours
Maternal quality of recovery
Measured using the ObsQoR-11 questionnaire
Measured: 24 hours
Resumption of oral diet post caesarean section.
Time until resumption of oral diet
Measured: 24 hours
Resumption of fluids post caesarean section.
Time until resumption of fluids
Measured: 24 hours
Post-operative nausea and vomiting (PONV)
The self reported incidence of PONV
Measured: 24 hours
PONV requiring treatment
PONV requiring pharmacological treatment
Measured: 24 hours
Pain scores
Pain scores at rest and movement on scale 0-10
Measured: 24 hours
Breastfeeding success
Binary - whether continuing attempted breast feeding at 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start20 Jan 2020
- Primary completion10 Aug 2021 (estimated)
- Study completion10 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arms with equal allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruairi Irwin, Coombe Women and Infants University Hospital
- Investigators
- Terry Tan, Study director, Head of Department of Anaesthesia CWIUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159948
- Sponsor's protocol ID
- CWIUH-CHO (16-2019)
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Carbohydrate Drink Prior to Elective Caesarean Section: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04159948
- Acronym / sponsor ID
- CWIUH-CHO (16-2019)
- Keywords
- Carbodydrate drink
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 10 Aug 2021 (estimated)
- First posted
- 12 Nov 2019 (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.
Prior to caesarean section, patients should fast from solid food for 6 hours and from clear fluids for 2 hours. Carbohydrate drinks can also be consumed up to 2 hours before surgery. These drinks have been shown to improve patient well-being after surgery and may potentially improve the neonatal blood glucose level after delivery and reduce the risk of a low blood glucose level. This study aims to assess the influence of pre-operative carbohydrate drinks on blood glucose levels of the baby at delivery.
Detailed description
Patients recruited to the study will be randomised to one of 3 groups.
Group 1 will receive standard care as per our current practice. This includes fasting from solids for 6 hours prior to surgery and clear fluids for up to 2 hours prior to surgery.
Group 2 will receive a carbohydrate (CHO) drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this CHO drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Group 3 will receive an apple juice drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this apple juice drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Before the start of surgery, the patients non-dominant hand grip strength will be assessed using the dynamometer. Their subjective sense of thirst and hunger will be assessed. Their fasting times for food and fluids will be recorded. The patients' blood glucose will be measured from a blood sample as their intravenous cannula is inserted. The maternal urinary ketones will be measured from a urine sample upon insertion.
The neonatal blood cord glucose will be measured from both an arterial and venous cord blood sample after delivery. This will be performed by the trained anaesthesia research fellow. Should hypoglycemia be identified, the hospital's neonatal hypoglycemia algorithm will be followed appropriately.
The patients will be followed up at 24 hours by an outcome assessor blinded to the group allocation. Numerical rating scale (NRS) pain scores, postoperative nausea and vomiting and quality of recovery will be assessed at the patients beside. All neonates will be followed up to calculate admissions to neonatal unit and the number of glucose sachets required for hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arms with equal allocation.
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Dietary Supplement: Carbohydrate drinkPatients will be allowed to drink water up to 2 hours before their caesarean section. |
| Carbohydrate drink | Active comparator | Dietary Supplement: Carbohydrate drinkPatients will be allowed to drink a designated carbohydrate drink up to 2 hours before their caesarean section. |
| Apple juice | Active comparator | Dietary Supplement: Carbohydrate drinkPatients will be allowed to drink apple juice up to 2 hours before their caesarean section. |
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.
- General anaesthesia.
- Gestation < 37 weeks.
- Steroids received within 4 days of delivery.
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 |
|---|---|---|
| Carbohydrate drinkThis is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes. | Dietary supplement | Apple juice, Carbohydrate drink, Water |
Primary outcome
Neonatal cord blood glucose
Time frame: 0 hours
A blood sample of the neonatal cord will be checked immediately after delivery.
14 secondary outcomes
Neonate tolerating 1st oral feeding.
Time frame: 0-2 hours
Number of neonatal rescue oral glucose sachets given.
Time frame: 6 hours
Neonate requiring ICU admission and treatment for hypoglycemia
Time frame: 6 hours
Maternal blood glucose
Time frame: 0 hours
Maternal urinary ketones
Time frame: 0 hours
Maternal subjective sense of thirst prior to the start of caesarean section.
Time frame: 0 hours
Maternal subjective sense of hunger prior to the start of caesarean section.
Time frame: 0 hours
Maternal quality of recovery
Time frame: 24 hours
Resumption of oral diet post caesarean section.
Time frame: 24 hours
Resumption of fluids post caesarean section.
Time frame: 24 hours
Post-operative nausea and vomiting (PONV)
Time frame: 24 hours
PONV requiring treatment
Time frame: 24 hours
Pain scores
Time frame: 24 hours
Breastfeeding success
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- 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.
Terry Tan study director
Head of Department of Anaesthesia CWIUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate drink in people with Fasting and Cesarean Delivery Affecting Fetus, run by Coombe Women and Infants University 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruairi Irwin (+353877497263, r.irwin1987@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal cord blood glucose (time frame: 0 hours). 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 2 Aug 2021.