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

Now open to recruitment!

Birmingham Clinical Trials Unit will be closed from 5pm Friday 20th December 2024 and will reopen Thursday 2nd January 2025.

 

The iHOLDS website and data collection system will remain active during this time for routine data entry and trial randomisations.

 

Serious Adverse Events should continue to be reported as normal during this time.

 

Please contact our iHOLDS inbox to get in touch with the team: iHOLDS@trials.bham.ac.uk

 

Merry Christmas!

 

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

 310

2400

10

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.