Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000879763p
Ethics application status
Submitted, not yet approved
Date submitted
15/05/2022
Date registered
21/06/2022
Date last updated
21/06/2022
Date data sharing statement initially provided
21/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
comparing the effect of a Dextrose solution on the length of labour in women undergoing an induction of labour
Scientific title
Evaluation of the effect of a Dextrose solution on the length of labour in nulliparous women undergoing an induction of labour - A Randomised controlled trial
Secondary ID [1] 307133 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
women having induction of labour (IOL) 326309 0
Prolonged labour 326310 0
Condition category
Condition code
Reproductive Health and Childbirth 323621 323621 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive intravenous infusion of 3.3% glucose in 0.3% sodium chloride (33g/l glucose) from time of rupture of membranes in birth suite until delivery of the placenta.
Intervention code [1] 323589 0
Treatment: Other
Comparator / control treatment
intravenous infusion of compound sodium lactate (Hartmann’s solution) from the time of rupture of membranes in birth suite until delivery of the placenta at 250 mls per hour.
Control group
Active

Outcomes
Primary outcome [1] 331380 0
duration of labour determined by review of the participant's medical record
Timepoint [1] 331380 0
birth
Secondary outcome [1] 409665 0
caesarean section rate determined by review of participant's medical records
Timepoint [1] 409665 0
birth
Secondary outcome [2] 409666 0
neonatal hypoglycaemia determined by blood tests
Timepoint [2] 409666 0
at any time during the first 24 hours after birth, assessed 2 hourly for the first 24 hours
Secondary outcome [3] 409667 0
maternal sodium levels determined by blood tests
Timepoint [3] 409667 0
4 and 24 hours after birth
Secondary outcome [4] 410198 0
5 min Apgar score determined by review of particpant's medical records
Timepoint [4] 410198 0
at 5 minutes after birth
Secondary outcome [5] 410199 0
admission to special care nursery determined by review of participant's medical records
Timepoint [5] 410199 0
after birth

Eligibility
Key inclusion criteria
Nulliparous women
booking BMI 25-40 kg/m2

induction of labour for postdates.
presentation is cephalic
singleton pregnancy.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
any medical or obstetrical problems

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sequentially numbered sealed opaque envelopes kept locked in birth suite
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated list of random numbers - assignment o intervention or control in groups of 20
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Chi squared
RR and 95% Confidence intervals

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/08/2023
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22368 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 37531 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 311437 0
Hospital
Name [1] 311437 0
west Moreton health service
Country [1] 311437 0
Australia
Primary sponsor type
Hospital
Name
West Moreton Hospital and Health Service
Address
1 chelmsford Ave
Ipswich
Queensland 4305
Country
Australia
Secondary sponsor category [1] 312832 0
None
Name [1] 312832 0
Address [1] 312832 0
Country [1] 312832 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310915 0
West Moreton Hospital and Health Service HREC
Ethics committee address [1] 310915 0
1 chelmsford Ave
Ipswich
Queensland 4305
Ethics committee country [1] 310915 0
Australia
Date submitted for ethics approval [1] 310915 0
21/06/2022
Approval date [1] 310915 0
Ethics approval number [1] 310915 0

Summary
Brief summary
Women normally receive Hartmann's solution in labour
we wish to provide them with more energy using a dextrose solution given slowly in labour to see if we can shorten their length of labour and possibly reduce caesarean section rate
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119330 0
A/Prof Kassam Mahomed
Address 119330 0
women's and children's services
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Queensland 4305
Country 119330 0
Australia
Phone 119330 0
+61407034283
Fax 119330 0
Email 119330 0
[email protected]
Contact person for public queries
Name 119331 0
Kassam Mahomed
Address 119331 0
women's and children's services
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Queensland 4305
Country 119331 0
Australia
Phone 119331 0
+61407034283
Fax 119331 0
Email 119331 0
[email protected]
Contact person for scientific queries
Name 119332 0
Kassam Mahomed
Address 119332 0
women's and children's services
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Queensland 4305
Country 119332 0
Australia
Phone 119332 0
+61407034283
Fax 119332 0
Email 119332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all outcome deidentified data on request
When will data be available (start and end dates)?
1/9/23 to 30/8/28
Available to whom?
any research upon request
Available for what types of analyses?
outcome data for the purpose of any IPD meta analysis
How or where can data be obtained?
by contacting PI via e mail:
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16074Study protocol    from PI - e mail [email protected]... [More Details] 384068-(Uploaded-15-05-2022-09-56-32)-Study-related document.docx
16075Informed consent form    384068-(Uploaded-15-05-2022-09-55-45)-Study-related document.doc
16076Ethical approval    awaiting submission and approval



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.