Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study

July 17, 2017 updated by: NHS Greater Glasgow and Clyde
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care in elective caesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients requiring general anaesthetic for surgical procedures are asked to stop eating and drinking for several hours before the procedure. This is due to concerns that such patients are at risk of lung damage caused by stomach contents entering their lungs while they are asleep (aspiration of gastric contents).

However, fasting patients for long periods of time can lower their ability to heal well and slow their recovery from surgery. Fasting increases anxiety levels and leads to poor patient satisfaction with the care received.

Recent studies have showed that allowing patients to drink clear, easily absorbed sugar rich liquids (carbohydrate drinks) until two hours prior to their anaesthetic does not expose them to extra risks while preventing the deleterious effects of starvation.

Carbohydrate drinks with a few other measures aimed at facilitating early recovery after surgeries are collectively termed Enhanced recovery after surgery (ERAS). The benefits and safety of enhanced recovery have been demonstrated in patients undergoing major bowel surgery and have been widely adopted. However, so far, no studies have been conducted to determine if these results apply to mothers undergoing planned caesarean sections. We hope to address this gap in the knowledge with our proposed study.

All mothers undergoing a planned caesarean section in the Princess Royal Maternity (PRM) will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care. Information collected from the groups will be compared to evaluate the expected benefits and risks. The study will continue until the target sample size of 100 mothers in each of the two study groups is reached.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mother scheduled for elective caesarean delivery at the Princess Royal Maternity Unit, Glasgow.

Exclusion Criteria:

  • Patient refusal
  • Severe oesophageal reflux disease (persistent daytime and night-time reflux in association with documented structural damage i.e. Barrett's Oesophagus.)
  • Diabetes mellitus requiring treatment beyond dietary modulation
  • Unable to consent
  • Patients undergoing general anaesthetic should be excluded from the study.
  • Anticipated complex caesarean section patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Mothers will be given six sachets of carbohydrate powder to be mixed in water . Instructions will be given to have two sachets in 800ml water at 10pm the night before and one sachet in 400ml water at 6 am on the morning of surgery. The order of the list will be decided at 8.45am on the morning of surgery by the surgical team. Mothers scheduled to have surgery later than 11am will be given a further sachet at 9.30am. Mothers scheduled for surgery after 1pm will be given a sachet at 9am and 11am.
Dietary supplement: Vitaflow Preload
Carbohydrate loading drink
No Intervention: Standard Care

Standard fasting instructions will given to mother:

Food until midnight before surgery 800ml water at 10pm night before surgery 400ml water at 6 am morning of surgery The order of the list will be decided at 8.45am on the morning of surgery by the surgical team.

Mothers scheduled to have surgery later than 11am will be given a further 400ml water at 9.30am. Mothers scheduled for surgery after 1pm will be given 400ml water at 9am and 11am.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery.
Time Frame: From insertion of urinary catheter until 5 minutes post urinary catherisation
After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer)
From insertion of urinary catheter until 5 minutes post urinary catherisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative thirst
Time Frame: On arrival to theatre - 5 minutes duration for questioning
Assessed via visual analogue scale
On arrival to theatre - 5 minutes duration for questioning
Preoperative hand grip strength
Time Frame: On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration
Dominant hand grip strength measures with dynamometer
On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration
Length of hospital stay
Time Frame: From admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed up to two weeks duration
Measured length of stay between hospital admission and discharge home
From admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed up to two weeks duration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of aspiration of gastric contents under general anaesthesia
Time Frame: From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to two weeks duration
Inhalation of gastric contents
From date of randomization until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to two weeks duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Obstetric Anaesthetists' Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN16OG711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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