Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Preoperative Carbohydrate Drink Prior to Elective Caesarean Section: A Randomized Controlled Trial.

Conditions
-----------------
Fasting, Cesarean Delivery Affecting Fetus, Glucose, Low Blood

Intervention / Treatment
-----------------
* Dietary Supplement: Carbohydrate drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 arms with equal allocation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Water<br>Patients will be allowed to drink water up to 2 hours before their caesarean section. | Dietary Supplement: Carbohydrate drink<br>* This is a commercially available pre-op carbohydrate drink used in enhanced recovery programmes.<br>|
| Active Comparator: Carbohydrate drink<br>Patients will be allowed to drink a designated carbohydrate drink up to 2 hours before their caesarean section. | Dietary Supplement: Carbohydrate drink<br>* This is a commercially available pre-op carbohydrate drink used in enhanced recovery programmes.<br>|
| Active Comparator: Apple juice<br>Patients will be allowed to drink apple juice up to 2 hours before their caesarean section. | Dietary Supplement: Carbohydrate drink<br>* This is a commercially available pre-op carbohydrate drink used in enhanced recovery programmes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal cord blood glucose | A blood sample of the neonatal cord will be checked immediately after delivery. | 0 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonate tolerating 1st oral feeding. | Binary outcome - Neonate consuming adequate breast or bottle milk. | 0-2 hours | 
| Number of neonatal rescue oral glucose sachets given. | Continuous - Number of neonatal rescue oral glucose sachets given. | 6 hours | 
| Neonate requiring ICU admission and treatment for hypoglycemia | Binary - Neonate requiring ICU admission and treatment for hypoglycemia | 6 hours | 
| Maternal blood glucose | Maternal blood glucose prior to the start of caesarean section. | 0 hours | 
| Maternal urinary ketones | Maternal urinary ketones prior to the start of caesarean section. | 0 hours | 
| Maternal subjective sense of thirst prior to the start of caesarean section. | Scored on a scale 0-10 | 0 hours | 
| Maternal subjective sense of hunger prior to the start of caesarean section. | Scored on a scale 0-10 | 0 hours | 
| Maternal quality of recovery | Measured using the ObsQoR-11 questionnaire | 24 hours | 
| Resumption of oral diet post caesarean section. | Time until resumption of oral diet | 24 hours | 
| Resumption of fluids post caesarean section. | Time until resumption of fluids | 24 hours | 
| Post-operative nausea and vomiting (PONV) | The self reported incidence of PONV | 24 hours | 
| PONV requiring treatment | PONV requiring pharmacological treatment | 24 hours | 
| Pain scores | Pain scores at rest and movement on scale 0-10 | 24 hours | 
| Breastfeeding success | Binary - whether continuing attempted breast feeding at 24 hours | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbodydrate drink