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Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159948
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ruairi Irwin, Coombe Women and Infants University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Fasting Cesarean Delivery Affecting Fetus Glucose, Low Blood Dietary Supplement: Carbohydrate drink Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 arms with equal allocation.
Masking: Single (Outcomes Assessor)
Masking Description: Patient will not be blinded to which arm they have been allocated to. Outcome assessors will be unaware of group allocation.
Primary Purpose: Treatment
Official Title: Preoperative Carbohydrate Drink Prior to Elective Caesarean Section: A Randomized Controlled Trial.
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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.




Primary Outcome Measures :
  1. Neonatal cord blood glucose [ Time Frame: 0 hours ]
    A blood sample of the neonatal cord will be checked immediately after delivery.


Secondary Outcome Measures :
  1. Neonate tolerating 1st oral feeding. [ Time Frame: 0-2 hours ]
    Binary outcome - Neonate consuming adequate breast or bottle milk.

  2. Number of neonatal rescue oral glucose sachets given. [ Time Frame: 6 hours ]
    Continuous - Number of neonatal rescue oral glucose sachets given.

  3. Neonate requiring ICU admission and treatment for hypoglycemia [ Time Frame: 6 hours ]
    Binary - Neonate requiring ICU admission and treatment for hypoglycemia

  4. Maternal blood glucose [ Time Frame: 0 hours ]
    Maternal blood glucose prior to the start of caesarean section.

  5. Maternal urinary ketones [ Time Frame: 0 hours ]
    Maternal urinary ketones prior to the start of caesarean section.

  6. Maternal subjective sense of thirst prior to the start of caesarean section. [ Time Frame: 0 hours ]
    Scored on a scale 0-10

  7. Maternal subjective sense of hunger prior to the start of caesarean section. [ Time Frame: 0 hours ]
    Scored on a scale 0-10

  8. Maternal quality of recovery [ Time Frame: 24 hours ]
    Measured using the ObsQoR-11 questionnaire

  9. Resumption of oral diet post caesarean section. [ Time Frame: 24 hours ]
    Time until resumption of oral diet

  10. Resumption of fluids post caesarean section. [ Time Frame: 24 hours ]
    Time until resumption of fluids

  11. Post-operative nausea and vomiting (PONV) [ Time Frame: 24 hours ]
    The self reported incidence of PONV

  12. PONV requiring treatment [ Time Frame: 24 hours ]
    PONV requiring pharmacological treatment

  13. Pain scores [ Time Frame: 24 hours ]
    Pain scores at rest and movement on scale 0-10

  14. Breastfeeding success [ Time Frame: 24 hours ]
    Binary - whether continuing attempted breast feeding at 24 hours



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159948


Contacts
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Contact: Ruairi Irwin +353877497263 r.irwin1987@gmail.com

Locations
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Ireland
Coombe Women and Infants University Hospital Recruiting
Dublin, Ireland
Contact: Ruairi Irwin    014085200      
Sponsors and Collaborators
Coombe Women and Infants University Hospital
Investigators
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Study Director: Terry Tan Head of Department of Anaesthesia CWIUH
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Responsible Party: Ruairi Irwin, Anaesthesia SpR, Coombe Women and Infants University Hospital
ClinicalTrials.gov Identifier: NCT04159948    
Other Study ID Numbers: CWIUH-CHO (16-2019)
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruairi Irwin, Coombe Women and Infants University Hospital:
Carbodydrate drink
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases