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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001137684
Acronym
FLUME
Enrollment
66
Registered
2023-11-03
Start date
2024-04-25
Completion date
2024-10-21
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a two-part study which involves two aims: 1. To develop a consumer- and evidence-informed maternal intrapartum hydration assessment and management intervention protocol for nulliparous women undergoing induction of labour which maintains maternal euvolaemia during parturition. 2. To evaluate the feasibility of undertaking a randomised control trial of the intervention developed in stage one with nulliparous women undergoing induction of labour within the RBWH.

Interventions

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 duri

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.

Sponsors

RBWH
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to 45 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026