iHOLDS

iHOLDS is a randomised, double blind, multi-centre study with a health economic evalutation and an internal pilot. 

The participants will be randomised in a 1:1 ratio to standard dose or a higher dose of oxytocin. 

To provide robust evidence of clinical effectiveness and costs of high dose compared to standard dose regimen of Syntocinon (oxytocin) for nulliparous women when prescribed during the induction of labour

Suitable participants will be identified in delivery suites at secondary and tertiary level hospitals across the UK.

Sample size of 2400 nulliparous women undergoing an induction for a singleton pregnancy where oxytocin has been prescribed. 

Exclusion criteria: nulliparous women who have existing cardiac disease, bleeding disorders, previous uterine surgery, or significant antepartum haemorrhage. Those under 16 years of age or with a known contra-indication to oxytocin therapy. 

High dose regimen (4mU/min increasing every 30 minutes to a maximum of 64mU/min) 

Standard dose regimen (2mU/min increasing every 30 minutes to a maximum 32mU/min)

Primary Outcome: Caesarean Section Rate (CSR)

Secondary Outcomes: Maternal and neonatal birth outcome data and a quantitative assessment of maternal psychological outcomes two weeks after birth 

Cost Comparison Outcomes: To assess the costs associated with a high dose regimen of oxytocin compared with the current standard dose, (on the basis of a within-trial study).  

The iHOLDS trial is funded by a NIHR Health Technology Assessment (HTA)  programme grant.