Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001206314p
Ethics application status
Submitted, not yet approved
Date submitted
12/08/2017
Date registered
17/08/2017
Date last updated
17/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the effect on babies of mothers consuming carbohydrate drink prior to caesarean delivery
Scientific title
Effect of peripartum maternal carbohydrate load pre caesarean section on neonatal blood glucose
Secondary ID [1] 292644 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnant women undergoing elective caesarean section 304377 0
Condition category
Condition code
Metabolic and Endocrine 303705 303705 0 0
Normal metabolism and endocrine development and function
Reproductive Health and Childbirth 303730 303730 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mothers will be randomised to either control or intervention arm.

Intervention arm women will be asked to consumed 200 grams of oral complex carbohydrate drink (Nutricia PreOp which contains 50 grams of complex carbohydrate per 200mls) the evening prior to elective caesarean section, and 100 grams on the morning of caesarean section. Mother and neonatal serum blood glucose level will be tested at fixed points following delivery of the fetus. Specifically fetal blood sugar will be measured at 4 and 10 hours of age - corresponding to before their second and fourth feed. Management of neonate blood sugar thereafter will be as per our local guideline.

Following randomisation and allocation of intervention or placebo arm, our research nurse with over 15 years experience will issue each study participant with their drink. This will take place face to face.

To ensure and maintain blinding, each study participant will receive a two drinks to consume. One the night prior to their caesarean section, and the second to be consumed between one and two hours prior to their surgery.

The first drink will be consumed at the participants home, and the second most likely in our day of surgery admission unit.

Prior to the testing of blood serum glucose concentration, study participants will be asked to verbally confirm that they have consumed both study drinks that were issued to them. verbal confirmation will be deemed adequate confirmation.
Intervention code [1] 298877 0
Treatment: Other
Comparator / control treatment
Control arm women will receive a simple sugar free flavoured water drink, both the night before and the day of surgery in a similar ilk to the intervention arm.

The remainder of their care will follow our local peri and post operative caesarean section pathway guidelines.
Control group
Placebo

Outcomes
Primary outcome [1] 303071 0
Neonatal blood glucose concentration
Timepoint [1] 303071 0
four and ten hours of age
Primary outcome [2] 303072 0
Admission to neonatal nursery for hypoglycaemia management
Neonatal record will provide means to identify admission to our neonatal nursery. This will be collated at time of final data collection / checking for each subject. Admission reason can be identified on neonatal discharge summary.
Timepoint [2] 303072 0
Within first 24 hours of life
Secondary outcome [1] 337821 0
Requirement of admission to neonatal nursery for any cause.
Neonatal record will provide means to identify admission to our neonatal nursery. This will be collated at time of final data collection and checking for each subject. Admission reason can be identified on neonatal discharge summary.
Timepoint [1] 337821 0
Duration of maternal and fetal admission
Secondary outcome [2] 337822 0
Maternal blood glucose concentration during caesarean section.
Timepoint [2] 337822 0
Maternal blood sugar will be checked during elective caesarean section. This will be after neuraxial blockade has been placed, but before fetus is delivered.
Secondary outcome [3] 337823 0
Requirement of neonate for formula supplementation during hospitalisation. On discharge from hospital, fetal medical records will be examined for documentation of necessity for neonatal formula feed top up.
Timepoint [3] 337823 0
Duration of hospitalisation
Secondary outcome [4] 337824 0
Maternal requirement of medication for postoperative nausea. This is defined as the administration of an additional anti-emetic medication above the routine administration of 4mg Ondansteron intravenously as part of routine caesarean section care.
Timepoint [4] 337824 0
Peri-operative period (Pre operative until leaving from Recovery room in theatre suite)
Secondary outcome [5] 337825 0
Length of hospital stay
Timepoint [5] 337825 0
Discharge from inpatient care

Eligibility
Key inclusion criteria
1. Pregnant women undergoing elective caesarean section
2. Term gestational age (37+0 to 41+6 weeks)
3. Singleton gestation
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with gestational diabetes and diabetes mellitus
2. Fetal intrauterine growth restriction
3. Ante-natally detected congenital anomaly which will require admission to neonatal nursery
4. Non English speaking

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8793 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 16916 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 297273 0
Charities/Societies/Foundations
Name [1] 297273 0
Australian Society of Anaesthetists
Country [1] 297273 0
Australia
Primary sponsor type
Individual
Name
Associate CLinical Professor Nolan McDonnell
Address
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth
6008
WA
Country
Australia
Secondary sponsor category [1] 296248 0
Individual
Name [1] 296248 0
Dr Elizabeth Beattie
Address [1] 296248 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth
6008
WA
Country [1] 296248 0
Australia
Secondary sponsor category [2] 296249 0
Individual
Name [2] 296249 0
Dr Abhijeet Rakshasbhuvankar
Address [2] 296249 0
King Edward Memorial Hospital
374 bagot Road
Subiaco
Perth
6008
WA
Country [2] 296249 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298390 0
Womans and Newborn Health Human Research Ethics Committee
Ethics committee address [1] 298390 0
374 Bagot Road
Subiaco
Perth
6008
WA
Ethics committee country [1] 298390 0
Australia
Date submitted for ethics approval [1] 298390 0
31/07/2017
Approval date [1] 298390 0
Ethics approval number [1] 298390 0

Summary
Brief summary
Background: An enhanced recovery strategy involves various pre, intra, and postoperative steps to reduce the normal stress response and organ dysfunction associated with surgical insult, with the ultimate aim of reducing time to full recovery. Preoperative carbohydrate administration is one of the components of an enhanced recovery strategy. However, preoperative carbohydrate treatment for pregnant women undergoing elective caesarean section has the potential to cause rebound hypoglycaemia in the newborn infant. The glycaemic control of newborn infants born to mothers receiving preoperative carbohydrate loading, as a part of an enhanced recovery strategy has not previously been studied.
Methods: We propose a pilot randomized controlled clinical trial to investigate the effect of preoperative carbohydrate loading in pregnant women undergoing elective caesarean section, on the glycaemic control of newborn infants. One hundred pregnant women scheduled for an elective caesarean section will be recruited after informed consent. They will be randomised to either intervention or control arm, and receive preoperative carbohydrate loading or no carbohydrate loading respectively. The remainder of their peri-operative management will be as per King Edward Memorial Hospital (KEMH) protocol for enhanced recovery. Newborn infants will be monitored for the risk of hypoglycaemia using KEMH neonatal unit guidelines for “infants at risk of hypoglycaemia”.
Outcomes: The primary outcomes will be blood glucose concentration in newborn infant at four and ten hours of life, and the requirement for admission to newborn nursery for the management of hypoglycaemia. Secondary outcomes will include maternal blood glucose concentration during caesarean section, maternal medication requirement for postoperative nausea, and length of hospital stay.
Significance: If the study shows that should this pilot study show that pre caesarean section carbohydrate does not increase risk of hypoglycaemia in newborn infants, we can safely introduce this component to our enhanced recovery protocol. Pre caesarean section carbohydrate loading has the potential to enhance maternal recovery and decrease length of hospital stay resulting in financial saving.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1965 1965 0 0
/AnzctrAttachments/373466-MCMG protocol v1.docx (Protocol)
Attachments [2] 1966 1966 0 0
/AnzctrAttachments/373466-Patient consent v2.doc (Participant information/consent)
Attachments [3] 1967 1967 0 0
/AnzctrAttachments/373466-6076_Carbohydrate info sheetv1.docx (Participant information/consent)
Attachments [4] 1968 1968 0 0
/AnzctrAttachments/373466-6075_Data record sheetv3.docx (Other)

Contacts
Principal investigator
Name 76922 0
A/Prof Nolan McDonnell
Address 76922 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth
6008
WA
Country 76922 0
Australia
Phone 76922 0
+6186458 2222
Fax 76922 0
Email 76922 0
Nolan.McDonnell@health.wa.gov.au
Contact person for public queries
Name 76923 0
Mrs Desiree Cavill
Address 76923 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth
6008
WA
Country 76923 0
Australia
Phone 76923 0
+6186458 2222
Fax 76923 0
Email 76923 0
Desiree.Cavill@health.wa.gov.au
Contact person for scientific queries
Name 76924 0
A/Prof Nolan McDonnell
Address 76924 0
King Edward Memorial Hospital
374 Bagot Road
Subiaco
Perth
6008
WA
Country 76924 0
Australia
Phone 76924 0
+6186458 2222
Fax 76924 0
Email 76924 0
Nolan.McDonnell@health.wa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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