For Women and Families

Information for Women and Family

We are doing a study to look at the best dose of a medicine (oxytocin) used for women who are having their labour induced.

Induction of labour

About 34% of (or one in three) 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 labour contractions have not yet started.

Labour can be induced in different ways.

  • Usually the cervix (neck of the womb) is softened using vaginal prostaglandins.
    • This means a small ‘tablet’ or ‘pessary’ is inserted into the vagina where it slowly starts to soften and open the neck of the womb over several hours.
    • Some women will go into labour at this point, but many still require their waters to be broken artificially. 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.

Artificial oxytocin/Syntocinon

Oxytocin is a natural hormone produced by the brain which plays a significant role in childbirth as it helps to make the muscles in the womb contract during labour.

There are man-made drugs almost identical to the natural hormone oxytocin which are widely used across UK Maternity Units and have been since the 1960s.

Syntocinon is one of these drugs, which helps the contractions build up to the best strength and speed to encourage vaginal birth. It is given by a drip into your arm.

All over the country the same standard dose and speed is used to increase the contractions to the best strength and frequency.

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).

If any concerning changes happen, the drug will be stopped or slowed down and this will usually settle the changes over a short period of time (i.e. over several minutes).

The iHOLDS Trial 

To enable us to answer our research question, we plan to recruit 2,400 first time mothers who require oxytocin during labour.

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 whether or not increasing the dose of oxytocin will reduce the chances of requiring a caesarean section.

While necessary, caesarean sections (also known as c-sections) generally result in longer hospital stays.

C-sections can increase the chance of complications for both mother and baby and are major surgery that most women would rather avoid.

Women whose first baby is delivered by caesarean section are also more likely to require caesarean sections for future babies. 

If you are offered an induction at one of these hospitals:

  • Birmingham Women’s Hospital

  • Great Western Hospital, Swindon

  • Princess Royal Hospital, Telford

  • Royal Cornwall Hospital

  • Royal Victoria Infirmary, Newcastle

  • Sunderland Royal Hospital

  • The Princess Royal Maternity Unit, Glasgow

  • University Hospital of North Tees

  • University Hospital of Wales, Cardiff

  • Wythenshawe Hospital, Manchester

Please contact us, and we can provide contact details for the research teams based at these hospitals.

Your midwife, Obstetrician or a member of the research team will talk to you about the iHOLDS study and go through the information leaflet with you to help you decide whether you would like to take part and answer any questions you may have. This may happen after you are admitted to hospital for your induction of labour. 

What will happen if you decide to join the trial?

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.

This study will compare the standard dose used routinely in hospitals, with a higher dose. The higher dose is already used in some hospitals.

The aim is to achieve regular contractions more quickly and allows a higher maximum dose to be used if necessary.

Women will be put into two different groups, and this will be decided ‘randomly’ using a computer. This is known as a randomised double-blind trial.

Information will be collected from your medical notes about your labour, birth, and care, before you and your baby go home, and this will be reported to the trial office.

Neither you nor your baby will need any extra tests or visits, we will ask you to complete a short multiple-choice questionnaire approximately two weeks after the birth of your baby, to find out how the birth experience was for you.

Taking part in the study will help us work out:

  • Whether a higher or lower dose of oxytocin can reduce the risk of caesarean section, whilst avoiding distress to mothers and babies.
  • What oxytocin dose is the best treatment for induction of labour in the future.

Patient and Public Involvement

To ensure that women’s views are at the heart of everything we do:

  • Public members sit on the panel which reviewed and agreed to fund the trial.

  • We have consulted a group of service users during the design of this study.

  • We have dedicated patient and public (PPI) representatives at every level in all trial management planning, and oversight groups.

  • They have helped to ensure all information provided to women is clear understandable and acceptable.

  •  PPI input will continue to be an integral part of the trial.

More information

The video links below are not related to the iHOLDS trial, but you may find them useful general information.  The iHOLDS trial does not recommend nor endorses any products, procedures, or other information that appears or may be advertised in the video links. Any medical information referred to in the links is given for information purposes only and is not intended to constitute medical advice. Please note that if you have any concerns about your pregnancy and care, please make sure you contact your doctor, midwife, or hospital immediately. 

Participant Information Leaflet (PDF)  iHOLDS Participant Information Leaflet (PIL) v1.0a 12May2021

Information about Induction of Labour A5 IOL info - community 25.02.21 v1 FINAL

Poster iHOLDS Public Facing Poster V1 14-Feb-22