Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001137684p
Ethics application status
Submitted, not yet approved
Date submitted
3/04/2023
Date registered
3/11/2023
Date last updated
28/01/2024
Date data sharing statement initially provided
3/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Fluids in Labour EnsUring Maternal Euvolemia (FLUME):
Co-design study and pilot randomized controlled trial for oral hydration for nulliparous women undergoing induction of labour
Scientific title
Fluids in Labour EnsUring Maternal Euvolemia (FLUME):
Co-design study and pilot randomized controlled trial for oral hydration for nulliparous women undergoing induction of labour
Secondary ID [1] 309340 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FLUME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal weight loss
 329539 0
Intrapartum maternal hydration 329540 0
Labour and birth 329541 0
Breastfeeding 329542 0
Condition category
Condition code
Reproductive Health and Childbirth 326475 326475 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 326476 326476 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A co-design, consensus-based activity was undertaken to develop the intervention arm of the study. This was developed in following evidence synthesis and in collaboration with representatives from obstetrics, anaesthetics, midwifery, neonatalology, lactation consultants, consumers and dietitians.

Women randomised to the intervention group will receive:
1. A brief (5-10 minutes) educational discussion (1-7 days prior to induction of labour) with the research midwife on optimising hydration during labour through oral intake. This discussion centres on advice on what, how much and when to eat and drink during labour.
2. No routine intravenous therapy administered as 'maintenance hydration' during labour
3. Intravenous boluses administered at clinician discretion (Hartmanns or Normal Saline 250-500 ml)

Midwives will be administering and monitoring all fluids and foods ingested. This will be documented on a Study specific Fluid Balance Chart, with all input and output measured and recorded.

Education will be provided face to face (twice weekly for 6 weeks) by a member of the research team in addition to a 10-minute recorded video which explains the study and intervention. This will be distributed to all midwifery and obstetrics staff working in Birthing suites within the study site. An information pack will also contain relevant documentation and will be held within the Birthing Suites. A log of all staff that have attended the education will be kept.
Intervention code [1] 325776 0
Treatment: Other
Comparator / control treatment
Standard Care, which involves:
1. No specific advice on what to eat and drink in labour (other than what is generally available)
2. Intravenous therapy of Hartmanns or Normal Saline @ 125ml/hr from commencement of oxytocin infusion for induction of labour, until birth of baby, as a maintenance fluid.
3. Intravenous boluses administered at clinician discretion as per usual care (Normal Saline or Hartmanns 250-500ml).
3. Unrestricted, ad hoc oral intake
Control group
Active

Outcomes
Primary outcome [1] 334361 0
Feasibility Outcome One: Eligibility (30% patient screened will be eligible)
Data source will be the study enrolment log
Timepoint [1] 334361 0
Trial completion
Primary outcome [2] 334701 0
The primary clinical outcome: The proportion of neonates born to nulliparous women undergoing Induction of Labour (IOL) to lose >7% of their birth weight on day 3 following birth.
Timepoint [2] 334701 0
Trial completion
Primary outcome [3] 334702 0
Feasibility Outcome Two: Recruitment (30% of eligible patients who consent to participate)
Data source will be the study enrolment log
Timepoint [3] 334702 0
Trial end
Secondary outcome [1] 420382 0
Feasibility Outcome Three: Retention and attrition (<5% of patients will be lost to follow up or withdraw consent); (<5% missing data)
Data source will be the study enrolment log
Timepoint [1] 420382 0
Trial completion
Secondary outcome [2] 421803 0
Feasibility Outcome Four: Patient acceptability and satisfaction (Likert scale >80% find intervention acceptable or very acceptable).
Collected in Maternal questionnaire with specific questions regarding acceptability of the intervention
Timepoint [2] 421803 0
Trial end
Secondary outcome [3] 421804 0
Maternal mode of birth, this is a standardised descriptor, routinely collected, and will be extracted from the medical record.
Timepoint [3] 421804 0
Trial end
Secondary outcome [4] 421805 0
Maternal perineal injury, this is a standardised descriptor, routinely collected, and will be extracted from the medical record.
Timepoint [4] 421805 0
Trial completion
Secondary outcome [5] 421806 0
Maternal postpartum haemorrhage, this is a standardised descriptor, routinely collected, and will be extracted from the medical record (estimated blood loss total volume will be collected here, as well as a diagnosed PPH [for a vaginal birth >500ml and c-section >1000ml])
Timepoint [5] 421806 0
Trial completion
Secondary outcome [6] 421807 0
Proportion of women experiencing delayed lactogenesis II, this will be diagnosed by the lactation consultant on the team and defined as a longer than usual (usual time is within 40 hours post-birth) interval between the colostrum phase and copious milk production, but whereby the mother has the ability to achieve full lactation. Data will be collected from lactation consultant notes within the patient medical record.
Timepoint [6] 421807 0
This will be measured on day 3 following birth only.
Secondary outcome [7] 421808 0
Proportion of women experiencing breast engorgement. This will be assessed using the Breast Edema Measurement Tool and categorised as: No edema (0); Slight edema (1+); Moderate edema (2+); Deep edema (3+); Very deep edema (4+). This will be measured on Day 1, and Day 3 following birth

Timepoint [7] 421808 0
Day 1 and Day 3 following birth.
Secondary outcome [8] 421809 0
Duration of the first stage of labour, measured in minutes.
Timepoint [8] 421809 0
Trial completion - this data is routinely collected and will be extracted from the client health record.
Secondary outcome [9] 421810 0
Proportion of neonates readmitted for jaundice within the first 28 days following birth.
The diagnosis of neonatal jaundice will be accessed from the NeoData database held within the RBWH or patient health record.
Timepoint [9] 421810 0
Trial completion
Secondary outcome [10] 421811 0
Quality of life (measured by SF-36)
Timepoint [10] 421811 0
6 weeks postpartum
Secondary outcome [11] 421812 0
Infant feeding methods/types. This is collected from the patient medical record, when mother / baby dyad are still an inpatient and then the 6 week postpartum point collected via a study-specific questionnaire.
Timepoint [11] 421812 0
Day 1, Day 3 and 6 weeks postpartum
Secondary outcome [12] 421813 0
Breastfeeding self-efficacy. This will be measured by the Breastfeeding self-efficacy scale short form (BSES-SF).
Timepoint [12] 421813 0
Measured at enrolment and 6 weeks postpartum
Secondary outcome [13] 427972 0
Proportion of neonates readmitted for feeding difficulties within the first 28 days following birth. This is collected via patient medical record.
Timepoint [13] 427972 0
Measured at 6 weeks postpartum

Eligibility
Key inclusion criteria
• 16 years and older
• Informed consent to participate
• Nulliparous
• Intending a vaginal birth
• Intention to breastfeed
• Onset of labour induced or augmented for prelabour rupture of membranes
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• A pre-existing condition (such as type 1 diabetes) which would indicate IV fluids in labour for a reason other than standard hydration
• Non-English speakers without interpreter
• Multiparous
• Planning an elective caesarean section
• Spontaneous onset of labour
• Diagnosed pre-eclampsia (as documented in patient medical record)
• Pre-existing cardiac condition pre-existing heart conditions with NYHA2-4 excluded.
• Anyone where fluid balance is going to be closely monitored (obstructive cardiac lesions like mitral stenosis or aortic stenosis)
• Renal conditions where high-volume fluid loading is contra-indicated
• Known fetal growth restriction
• Not intending to breastfeed

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)
RedCAP randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be assigned using a central, web-based randomisation service, with allocation concealment, in a 1:1 ratio to standard care (block sizes of 4 and 6) or intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Feasibility outcomes will be reported descriptively and assessed in terms of the implications for a fully powered study. Baseline variables and secondary outcomes will be used to calculate estimates of effects, rather than inferential analysis, as this study is not powered to detect this. A costing analysis, incorporating length of stay information, will be undertaken to inform the development of an economic evaluation in a future trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
24/02/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24454 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 40036 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 313540 0
Charities/Societies/Foundations
Name [1] 313540 0
Study, Education and Trust Fund, RBWH
Country [1] 313540 0
Australia
Primary sponsor type
Hospital
Name
RBWH
Address
Women's and Newborn ServicesLevel 6, Ned Hanlon BuildingRoyal Brisbane and Women's HospitalMetro North Health Butterfield StHerston Qld 4029
Country
Australia
Secondary sponsor category [1] 315317 0
Hospital
Name [1] 315317 0
The University of Queensland
Address [1] 315317 0
St Lucia, QLD, 4067
Country [1] 315317 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312723 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 312723 0
Ethics committee country [1] 312723 0
Australia
Date submitted for ethics approval [1] 312723 0
17/04/2023
Approval date [1] 312723 0
Ethics approval number [1] 312723 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125674 0
A/Prof Lauren Kearney
Address 125674 0
Level 6, Women's and Newborn Services,Royal Brisbane and Women's Hospital.Butterfield St Herston QLD 2006
Country 125674 0
Australia
Phone 125674 0
+61403606546
Fax 125674 0
Email 125674 0
[email protected]
Contact person for public queries
Name 125675 0
Lauren Kearney
Address 125675 0
Level 6, Women's and Newborn Services,Royal Brisbane and Women's Hospital.Butterfield St Herston QLD 2006
Country 125675 0
Australia
Phone 125675 0
+61403606546
Fax 125675 0
Email 125675 0
[email protected]
Contact person for scientific queries
Name 125676 0
Lauren Kearney
Address 125676 0
Level 6, Women's and Newborn Services,Royal Brisbane and Women's Hospital.Butterfield St Herston QLD 2006
Country 125676 0
Australia
Phone 125676 0
+61403606546
Fax 125676 0
Email 125676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot only - and is not powered to detect clinically significant differences. If deemed feasible in this pilot, a definitive trial will be conducted and IPD sharing will be considered at that time.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18784Study protocol  [email protected]
18785Statistical analysis plan  [email protected]



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.