Preoperative Carbohydrate Drink Prior to Elective Caesarean Section
NCT ID: NCT04159948
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
69 participants
INTERVENTIONAL
2020-01-20
2021-08-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Carbohydrate Loading Fasting Protocol Versus 'Sip Til Send'
NCT06505915
Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study
NCT03220997
Impact of Oral Carbohydrate Consumption Prior to Cesarean Section
NCT02684513
Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section
NCT03732404
Gastric Voume Assessment for Aspiration Risk in OB ERAS Patients
NCT03842527
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Water
Patients will be allowed to drink water up to 2 hours before their caesarean section.
Carbohydrate drink
This is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes.
Carbohydrate drink
Patients will be allowed to drink a designated carbohydrate drink up to 2 hours before their caesarean section.
Carbohydrate drink
This is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes.
Apple juice
Patients will be allowed to drink apple juice up to 2 hours before their caesarean section.
Carbohydrate drink
This is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Carbohydrate drink
This is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects able to give informed consent and willing to comply with the study protocol.
* Subjects must be greater than 18 years old.
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Coombe Women and Infants University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ruairi Irwin
Anaesthesia SpR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Terry Tan
Role: STUDY_DIRECTOR
Head of Department of Anaesthesia CWIUH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Coombe Women and Infants University Hospital
Dublin, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ruairi Irwin
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CWIUH-CHO (16-2019)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.