NCT03220997

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

June 6, 2017

Last Update Submit

July 17, 2017

Conditions

StarvationCaesarean Section

Keywords

SequelaKetosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery.

    After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer)

    From insertion of urinary catheter until 5 minutes post urinary catherisation

Secondary Outcomes (3)

  • Preoperative thirst

    On arrival to theatre - 5 minutes duration for questioning

  • Preoperative hand grip strength

    On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration

  • Length of hospital stay

    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 Outcomes (1)

  • Incidence of aspiration of gastric contents under general anaesthesia

    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

Study Arms (2)

Interventional

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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.

Interventions

Vitaflow PreloadDIETARY_SUPPLEMENT

Carbohydrate loading drink

Interventional

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • Obstetric Anaesthetists' Association (2012). GENERAL ANAESTHETIC FOR UNPLANNED CAESAREAN SECTION (CS) INFORMATON CARD. http://www.labourpains.com/assets/_managed/editor/File/Info%20for%20Mothers/GA%20for%20unplanned%20CS/GA_Unplanned_CS.pdf.pdf accessed 23/04/15.

    BACKGROUND

  • Clark, A & Agaram, R. (2014) Too fast? Ketonuria as a marker of prolonged fasting in elective caesarean section. International Journal of Obstetric Anaesthesia 23, Supplement 1, S1-S62.

    BACKGROUND

  • Metzger BE, Ravnikar V, Vileisis RA, Freinkel N. "Accelerated starvation" and the skipped breakfast in late normal pregnancy. Lancet. 1982 Mar 13;1(8272):588-92. doi: 10.1016/s0140-6736(82)91750-0.

    PMID: 6121184BACKGROUND

  • Agarwal A, Chari P, Singh H. Fluid deprivation before operation. The effect of a small drink. Anaesthesia. 1989 Aug;44(8):632-4. doi: 10.1111/j.1365-2044.1989.tb13581.x.

    PMID: 2782569BACKGROUND

  • Lucas DN, Gough KL. Enhanced recovery in obstetrics--a new frontier? Int J Obstet Anesth. 2013 Apr;22(2):92-5. doi: 10.1016/j.ijoa.2013.02.001. Epub 2013 Mar 9. No abstract available.

    PMID: 23477889BACKGROUND

  • Wong CA, Loffredi M, Ganchiff JN, Zhao J, Wang Z, Avram MJ. Gastric emptying of water in term pregnancy. Anesthesiology. 2002 Jun;96(6):1395-400. doi: 10.1097/00000542-200206000-00019.

    PMID: 12170052BACKGROUND

  • Wong CA, McCarthy RJ, Fitzgerald PC, Raikoff K, Avram MJ. Gastric emptying of water in obese pregnant women at term. Anesth Analg. 2007 Sep;105(3):751-5. doi: 10.1213/01.ane.0000278136.98611.d6.

    PMID: 17717235BACKGROUND

  • Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

    PMID: 21712716BACKGROUND

  • Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.

    PMID: 23052794BACKGROUND

  • Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.

    PMID: 8526579BACKGROUND

  • Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: 10.1001/archsurg.2010.309. Epub 2011 Jan 17.

    PMID: 21242424BACKGROUND

  • Clark A, Litchfield K, Hannah S, Love C, Slade K, Lake K, Agaram R. Pre-operative carbohydrate loading prior to elective caesarean delivery: a randomised controlled trial. Int J Obstet Anesth. 2021 Feb;45:21-27. doi: 10.1016/j.ijoa.2020.10.008. Epub 2020 Oct 18.

    PMID: 33277162BACKGROUND

  • Neufer PD, Costill DL, Flynn MG, Kirwan JP, Mitchell JB, Houmard J. Improvements in exercise performance: effects of carbohydrate feedings and diet. J Appl Physiol (1985). 1987 Mar;62(3):983-8. doi: 10.1152/jappl.1987.62.3.983.

    PMID: 3571097BACKGROUND

  • Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7.

    PMID: 18331374BACKGROUND

  • Scott MJ, Fawcett WJ. Oral carbohydrate preload drink for major surgery - the first steps from famine to feast. Anaesthesia. 2014 Dec;69(12):1308-13. doi: 10.1111/anae.12921. Epub 2014 Oct 23. No abstract available.

    PMID: 25346490RESULT

MeSH Terms

Conditions

StarvationKetosis

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesAcidosisAcid-Base ImbalanceMetabolic Diseases

Central Study Contacts

Andrew Clark

CONTACT

07841525587andrewclark85@gmail.com

Kerry Litchfield

CONTACT

0141 2114620klitchfield@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Research midwives will attend consent, randomise, collect baseline data and provide the accompanying information and carbohydrate sachets to subjects. The research fellows will be blinded but will collect the data for participants. The research midwives will complete study compliance. To achieve this, participants will bring to ward a completed compliance form ( given at randomisation) in a sealed envelope this will ensure the research investigators remain blinded during their pre op assessments and data collection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

July 18, 2017

Study Start

August 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 18, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share