Clinical trial NCT04159948: Preoperative Carbohydrate Drink Prior to Elective Caesarean Section
Official title: Preoperative Carbohydrate Drink Prior to Elective Caesarean Section: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasting
Cesarean Delivery Affecting Fetus
Glucose, Low Blood
Keywords: Carbodydrate drink
Lead sponsor: Coombe Women and Infants University Hospital
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arms with equal allocation.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neonatal cord blood glucose
timeFrame: 0 hours
Secondary outcomes:
measure: Neonate tolerating 1st oral feeding.
timeFrame: 0-2 hours
measure: Number of neonatal rescue oral glucose sachets given.
timeFrame: 6 hours
measure: Neonate requiring ICU admission and treatment for hypoglycemia
timeFrame: 6 hours
measure: Maternal blood glucose
timeFrame: 0 hours
measure: Maternal urinary ketones
timeFrame: 0 hours
measure: Maternal subjective sense of thirst prior to the start of caesarean section.
timeFrame: 0 hours
measure: Maternal subjective sense of hunger prior to the start of caesarean section.
timeFrame: 0 hours
measure: Maternal quality of recovery
timeFrame: 24 hours
measure: Resumption of oral diet post caesarean section.
timeFrame: 24 hours
measure: Resumption of fluids post caesarean section.
timeFrame: 24 hours
measure: Post-operative nausea and vomiting (PONV)
timeFrame: 24 hours
measure: PONV requiring treatment
timeFrame: 24 hours
measure: Pain scores
timeFrame: 24 hours
measure: Breastfeeding success
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Coombe Women and Infants University Hospital
Study officials:
affiliation: Head of Department of Anaesthesia CWIUH
name: Terry Tan
role: STUDY_DIRECTOR
References: