Information for Women and Families
This Trial is funded by the NIHR Health Technology Assessment (HTA) programme.
Background to HOLDS trial
About 34% (or one in three) of first-time mothers have their labour induced. Labour induction is the process we use to start labour artificially. This may be required for a variety of reasons, most commonly because you have gone past your due date, or because your waters have broken but your labour contractions have not yet started. If contractions still do not start, a drug is given using a drip in the arm to start them off. The drug used is artificial Oxytocin and this is given to around 60% of women (six in ten) who have labour induced. This drug will help contractions build up to an ideal strength and frequency to encourage a vaginal birth.
All women and their babies having Oxytocin are monitored closely and you will be looked after by an identified midwife on the Labour Ward who will also be monitoring the baby’s heart rate continuously using Electronic Fetal Monitoring (EFM).
Many mothers who undergo induction of labour (including those who receive Oxytocin) require an unplanned caesarean section to safely deliver their baby.
We want to find out if increasing the dose of Oxytocin will reduce the chances of requiring a caesarean section.
As we don’t know which dose is best, the iHOLDS Trial will compare the standard dose with the higher dose in a ‘randomised trial’. Women will be put into two different groups and this will be decided ‘randomly’ using a computer.
In the study, neither you nor your midwife or obstetrician will know which group you are in, so they will not know whether you are given the standard or higher dose. If you decide to join the study, both you and your baby will be closely monitored throughout, in the same way as you would if you were receiving standard of care Oxytocin.
How many women are needed to join the Trial?
2400 women
How to get involved in the trial
All women having their first baby, booked for an induction of labour will be provided with information about the trial during late pregnancy.
If an induction of labour is booked for you a midwife or obstetrician will talk to you about the trial.
If you decide not to be involved in the trial your care will not be affected in any way.
Please contact your midwife if you require any further information on the trial or the trials unit.
Who Can Enter the Trial?
See inclusion/exclusion criteria
Which Hospitals are running the trial
<Space to insert hospital names>
Patient and Public Involvement
Involving members of the public in designing and reviewing the trials is very important to us.
Public members sit on the panel which reviewed and agreed to fund the trial. We have dedicated patient and public (PPI) representatives on both our Trial Steering Committee and Co-Applicants Group who have helped to ensure all information provided to women is clear and understandable.
Documents
Participant Information Leaflet (PDF) iHOLDS Participant Information Leaflet (PIL) v1.0a 12May2021
Lay Summary (PDF) iHOLDS Lay Summary v1.0 14Dec20
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