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

Not Applicable

• Conditions: eonatal weight loss; Intrapartum maternal hydration; Labour and birth; Breastfeeding; Neonatal weight loss; Reproductive Health and Childbirth - Childbirth and postnatal care; Reproductive Health and Childbirth - Breast feeding

• Registration Number: ACTRN12623001137684
• Lead Sponsor: RBWH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-03
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility Outcome One: Eligibility (30% patient screened will be eligible)<br>Data source will be the study enrolment log[ Trial completion];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. [ Trial completion ];Feasibility Outcome Two: Recruitment (30% of eligible patients who consent to participate)<br>Data source will be the study enrolment log[ Trial end ]