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

Primary Purpose

Starvation, Caesarean Section

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitaflow Preload
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Starvation focused on measuring Sequela, Ketosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Interventional

    Standard Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Preoperative thirst
    Assessed via visual analogue scale
    Preoperative hand grip strength
    Dominant hand grip strength measures with dynamometer
    Length of hospital stay
    Measured length of stay between hospital admission and discharge home

    Full Information

    First Posted
    June 6, 2017
    Last Updated
    July 17, 2017
    Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    Obstetric Anaesthetists' Association
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03220997
    Brief Title
    Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study
    Official Title
    Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    Obstetric Anaesthetists' Association

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Starvation, Caesarean Section
    Keywords
    Sequela, Ketosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interventional
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitaflow Preload
    Intervention Description
    Carbohydrate loading drink
    Primary Outcome Measure Information:
    Title
    Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery.
    Description
    After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer)
    Time Frame
    From insertion of urinary catheter until 5 minutes post urinary catherisation
    Secondary Outcome Measure Information:
    Title
    Preoperative thirst
    Description
    Assessed via visual analogue scale
    Time Frame
    On arrival to theatre - 5 minutes duration for questioning
    Title
    Preoperative hand grip strength
    Description
    Dominant hand grip strength measures with dynamometer
    Time Frame
    On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration
    Title
    Length of hospital stay
    Description
    Measured length of stay between hospital admission and discharge home
    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
    Other Pre-specified Outcome Measures:
    Title
    Incidence of aspiration of gastric contents under general anaesthesia
    Description
    Inhalation of gastric contents
    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

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew Clark
    Phone
    07841525587
    Email
    andrewclark85@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kerry Litchfield
    Phone
    0141 2114620
    Email
    klitchfield@nhs.net

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
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    PubMed Identifier
    6121184
    Citation
    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.
    Results Reference
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    PubMed Identifier
    2782569
    Citation
    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.
    Results Reference
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    PubMed Identifier
    23477889
    Citation
    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.
    Results Reference
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    PubMed Identifier
    12170052
    Citation
    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.
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    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.
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    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.
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    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.
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    Results Reference
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    Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study

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