Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159948
• Other study ID #: CWIUH-CHO (16-2019)
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: July 2021
• Source: Coombe Women and Infants University Hospital
• Contact: Ruairi Irwin
• Phone: +353877497263
• Email: r.irwin1987[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Fasting
• Glucose, Low Blood
• Hypoglycemia

Intervention

Dietary Supplement:
• Carbohydrate drink
This is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes.

Locations

Country	Name	City	State
Ireland	Coombe Women and Infants University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Coombe Women and Infants University Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

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