Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001298808
Ethics application status
Approved
Date submitted
14/08/2021
Date registered
24/09/2021
Date last updated
19/09/2022
Date data sharing statement initially provided
24/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled study In women undergoing an induction of labour to determine if the rate of intravenous fluid used impacts upon the duration of labour
Scientific title
Effect of intravenous fluid restriction on the duration of labour in women requiring an induction of labour - a pilot study
Secondary ID [1] 305045 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labour 323493 0
Condition category
Condition code
Reproductive Health and Childbirth 320813 320813 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. Women requiring an induction of labour with oxytocin will be randomised to a background infusion of Hartmann's Compound Sodium Lactate (CSL) at 40 ml/hr.

The background infusion of Hartmann's CSL will commence at the time of induction of labour, which is defined as the commencement of a separate intravenous infusion of oxytocin. The midwife caring for this patient will be responsible for the commencement of the intravenous line of oxytocin, as well as commencement of the intravenous line of Hartmann's CSL. The background infusion of Hartmann's CSL will cease, at the same time that the intravenous infusion of oxytocin ceases, which is post delivery of the placenta. The third stage of labour will be actively managed by controlled cord traction of the placenta and IM injection of 10 IU of oxytocin into the thigh of the woman. The background infusion of Hartmann's is a continuous infusion, the rate of which is not varied throughout labour. No intravenous fluid boluses of Hartmann's CSL or any other crystalloid is allowed for this study. The appropriate rate of the background infusion of Hartmann's CSL will be verified by an audit of the patient's fluid chart.
Intervention code [1] 321441 0
Treatment: Other
Comparator / control treatment
Arm 2. Women requiring an induction of labour with oxytocin will be randomised to a background infusion of Hartmann's CSL at 250 ml/hr.

The background infusion of Hartmann's CSL will commence at the time of induction of labour, which is defined as the commencement of a separate intravenous infusion of oxytocin. The midwife caring for this patient will be responsible for the commencement of the intravenous line of oxytocin, as well as commencement of the intravenous line of Hartmann's CSL. The background infusion of Hartmann's CSL will cease, at the same time that the intravenous infusion of oxytocin ceases, which is post delivery of the placenta. The third stage of labour will be actively managed by controlled cord traction of the placenta and IM injection of 10 IU of oxytocin into the thigh of the woman. The background infusion of Hartmann's is a continuous infusion, the rate of which is not varied throughout labour. No intravenous fluid boluses of Hartmann's CSL or any other crystalloid is allowed for this study. The appropriate rate of the background infusion of Hartmann's CSL will be verified by an audit of the patient's fluid chart.
Control group
Active

Outcomes
Primary outcome [1] 328619 0
The total duration of labour as defined by the commencement of the oxytocin infusion until the birth of the neonate (measured in minutes). This will be determined by accessing the various documented time points in the patient's medical record, i.e. the documented time of commencement of the intravenous line of oxytocin and the documented time of birth of the neonate. The duration of the two separate time points in minutes will be calculated to determine the duration of labour.
Timepoint [1] 328619 0
By accessing the patient's medical file the duration of labour will be determined by the calculation in minutes from the documented time of commencement of the oxytocin infusion, to the documented time of birth of the neonate.
Secondary outcome [1] 399661 0
The incidence of emergency caesarean section will be assessed by accessing the obstetrician notes documented in the patient's medical record and noting the type of birth documented.
Timepoint [1] 399661 0
Time of birth
Secondary outcome [2] 399662 0
The incidence of instrumental delivery (forceps or ventouse) will be assessed by accessing the obstetrician notes documented in the patient's medical record and noting the type of birth documented.
Timepoint [2] 399662 0
Time of birth
Secondary outcome [3] 399663 0
The incidence of postpartum haemorrhage defined as >= 500 ml will be assessed by accessing the obstetrician and/or midwifery notes documented in the patient's medical record. This outcome may be assessed by either the midwife or the obstetrician by the weighing of blood soaked sheets and pads, or by an estimation of the blood loss. Whatever is recorded in the patient's medical file will be the amount documented for this study.
Timepoint [3] 399663 0
24 hours post time of birth
Secondary outcome [4] 399664 0
The incidence of epidural analgesia will be assessed by accessing the patient's medical record and noting the presence of an epidural chart and documentation of the placement of an epidural cathether by the anaesthetist.
Timepoint [4] 399664 0
From the time of placement of the epidural catheter
Secondary outcome [5] 399665 0
The incidence of neonatal admission to the special care nursery will be assessed by accessing the neonate's medical record and noting the presence of a written admission entry of the neonate to the special care nursery.
Timepoint [5] 399665 0
Up to 14 days post birth of the neonate
Secondary outcome [6] 399666 0
The incidence of exclusive breast feeding at one month will be determined by a telephone call to the mother of the neonate and asking three questions. 1. Are you breastfeeding only? 2. Are you having to give supplemental feeds with formula? 3. Are you formula feeding only?
Timepoint [6] 399666 0
1 month post day of birth
Secondary outcome [7] 399667 0
The incidence of exclusive breast feeding at three months will be determined by a telephone call to the mother of the neonate and asking three questions. 1. Are you breastfeeding only? 2. Are you having to give supplemental feeds with formula? 3. Are you formula feeding only?
Timepoint [7] 399667 0
3 months post day of birth

Eligibility
Key inclusion criteria
Pregnant women of 37 weeks or greater gestational age, with a single pregnancy in a cephalic presentation who require an induction of labour
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < than 18 years
Inability to consent
Augmentation of labour, rather than induction of labour
Pre-eclampsia
Previous caesarean section
Multiple pregnancy

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)
Central randomisation by computer and sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Post hoc analysis of a previous study in which 200 women who were having an induction of labour were enrolled, showed that for those women who had a protocol violation as determined by the provision of a bolus of fluid had a 40% increase in emergency caesarean section rate, when compared to women who did not have a bolus of fluid. For that particular study, all women who participated had a background infusion rate of Hartmann's at 40 ml/hr. Other studies in the literature are suggestive of the fact that women who receive an infusion of a crystalloid solution at 250 ml/hr relative to those who receive the same fluid at 125 ml/hr have a shorter duration of labour and a statistically reduced incidence of emergency caesarean sections. We therefore chose to compare 40 ml/hr versus 250 ml/hr in 200 women requiring an induction of labour. As induction of labour is relatively common (40% of first time pregnant women), it will only take 1-2 months to recruit this number of participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/10/2021
Actual
22/11/2021
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
200
Accrual to date
160
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20244 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 34983 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 309442 0
Hospital
Name [1] 309442 0
The Northern Hospital
Country [1] 309442 0
Australia
Primary sponsor type
Individual
Name
Dr Darren Lowen
Address
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country
Australia
Secondary sponsor category [1] 310409 0
None
Name [1] 310409 0
Address [1] 310409 0
Country [1] 310409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309234 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 309234 0
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 309234 0
Australia
Date submitted for ethics approval [1] 309234 0
08/06/2021
Approval date [1] 309234 0
12/08/2021
Ethics approval number [1] 309234 0
HREC/75301/Austin-2021

Summary
Brief summary
This is a randomised controlled study of women who require an induction of labour, to determine if excess, or inappropriate infusions of fluid given via a vein (intravenous route) is having an effect upon the duration of labour. For this study, women who require an induction of labour will be randomised to receive intravenous fluid at a rate of 40 ml/hr or 250 ml/hr. The duration of labour (in minutes), will be calculated from the commencement of an intravenous infusion of a medication to start labour (a hormone called oxytocin), until the birth of the baby.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113442 0
Dr Darren Lowen
Address 113442 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 113442 0
Australia
Phone 113442 0
+61 402 832 336
Fax 113442 0
+61 3 8405 8032
Email 113442 0
[email protected]
Contact person for public queries
Name 113443 0
Dr Darren Lowen
Address 113443 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 113443 0
Australia
Phone 113443 0
+61 402 832 336
Fax 113443 0
+61 3 8405 8032
Email 113443 0
[email protected]
Contact person for scientific queries
Name 113444 0
Dr Darren Lowen
Address 113444 0
Department of Anaesthesia & Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 113444 0
Australia
Phone 113444 0
+61 402 832 336
Fax 113444 0
+61 3 8405 8032
Email 113444 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 of the individual participant data collected during the trial after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal on a case by case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
To achieve the aims in the approved proposal or for IPD meta-analyses
How or where can data be obtained?
Access will be subject to approval by the Principal Investigator who may be contacted at [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



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.