Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

Coombe Women and Infants University Hospital

Status: Unknown

Conditions: Cesarean Delivery Affecting Fetus; Fasting; Glucose, Low Blood

Treatments: Dietary Supplement: Carbohydrate drink

Study type: Interventional

Funder types: Other

Identifiers

NCT04159948

CWIUH-CHO (16-2019)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 3 patient groups, including a placebo group

Water

Placebo Comparator group

Description:

Patients will be allowed to drink water up to 2 hours before their caesarean section.

Treatment:

Dietary Supplement: Carbohydrate drink

Carbohydrate drink

Active Comparator group

Description:

Patients will be allowed to drink a designated carbohydrate drink up to 2 hours before their caesarean section.

Treatment:

Dietary Supplement: Carbohydrate drink

Apple juice

Active Comparator group

Description:

Patients will be allowed to drink apple juice up to 2 hours before their caesarean section.

Treatment:

Dietary Supplement: Carbohydrate drink