Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fasting; Glucose, Low Blood; Cesarean Delivery Affecting Fetus
• Intervention / Treatment: Dietary supplement: Carbohydrate drink

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.

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Coombe Women and Infants University Hospital
    • Contact: Ruairi Irwin; Phone Number: 014085200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Coombe Women and Infants University Hospital
• Investigators: Study Director: Terry Tan, Head of Department of Anaesthesia CWIUH

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): August 10, 2021
• Study Completion (Anticipated): August 10, 2021

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Carbodydrate drink
• Other Study ID Numbers: CWIUH-CHO (16-2019)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No