iHOLDS

The iHOLDS trial is a randomised double blinded, multi-centre study looking at standard dose vs a higher dose of oxytocin on the rate of caesarean section in induction of labour. 

iHOLDS logo

 

Thank you to all the women, birthing people and staff who took part in the iHOLDS trial. We are now gathering and looking over all the information we collected, and we don't need anyone else to join the study at this time. We look forward to sharing the results with you, probably in the late spring next year once everything has been reviewed.

Recruitment summary (updated 07th February 2023)
Participants RandomisedTarget participants randomised Sites opened        Target sites opened        

 989

2400

16

20

The following map shows the current locations of participating sites:


Design

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. 

Aim of the Study

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

Setting

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

Target Population

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. 

Intervention (Oxytocin)

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)

Measurement of outcomes

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).  

Funding

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