CompletedNot ApplicableInterventional

The iHOLDS Trial: High Or Low Dose Syntocinon for induction of labour

Induction of labour means starting labour artificially. In the UK, about one in three first-time mothers are induced, often because their baby is overdue or their waters broke early. If contractions do not start naturally, doctors use a drip containing oxytocin (Syntocinon) to get the womb contracting. Sometimes, labour does not progress as hoped, leading to an unplanned caesarean section. While caesareans are safe and often necessary, they are major operations that require a longer recovery time. The iHOLDS trial tests whether giving a higher dose of oxytocin helps labour progress more effectively than the standard dose. Researchers want to find out if this reduces the need for emergency caesareans. First-time mothers who join are randomly chosen to receive either the standard dose or the higher dose. Both mother and baby are monitored very closely throughout labour.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Birmingham Women’s and Children’s NHS Foundation Trust

Enrolment target

2,400

Start

01 Sep 2021

Estimated completion

31 May 2023

Induction of labour

What is this study about?

In the UK, about one in three first-time mothers have their labour induced. Induction is recommended when doctors feel it is safer for the baby to be born soon rather than waiting. If gentle methods like hormone gels or breaking the waters do not get labour started, doctors commonly give a medication called oxytocin through a drip in the arm. Oxytocin copies a natural body hormone that helps the womb muscles contract.

While oxytocin is widely used, many induced labours still end in an unplanned caesarean section. A caesarean section is major surgery. It usually means a longer hospital stay, a slower recovery, and a higher chance of needing a caesarean for future births. Doctors want to find safe ways to help more women have a straightforward vaginal birth when being induced.

The iHOLDS trial is testing whether starting with a higher dose of oxytocin works better than the current standard dose. The aim is to help contractions become regular more quickly. By comparing the standard dose with a higher dose, the trial team hopes to discover if the higher dose safely lowers the chance of needing an unplanned caesarean.

Key takeaways

The iHOLDS trial tests whether a higher dose of oxytocin helps reduce unplanned caesarean sections.
It is designed for first-time mothers aged 16 and over whose labour is being induced.
Participants receive either the standard dose or a higher dose of oxytocin through a drip in the arm.
You and your baby will receive continuous, close monitoring throughout your labour.
Follow-up involves completing a short questionnaire at home two weeks after giving birth.

Who may be eligible?

This study is open to first-time mothers aged 16 or older who are having their labour induced at a participating hospital. To take part, you must be pregnant with a single baby who is lying head-down, and your waters must have already broken.

Your maternity team must also have decided that an oxytocin drip is needed to help your contractions start. Women can be induced for many common reasons, such as being past their due date, having high blood pressure, or having gestational diabetes.

Women carrying twins or multiples, or those who have had a baby before, cannot take part. Your midwife or doctor will always check whether the trial is safe and suitable for you and your baby before you join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You are having your first baby (no previous births past 24 weeks).
You are aged 16 or older.
You are pregnant with one baby who is positioned head-first.
Your waters have broken and you need an oxytocin drip to help start your contractions.
You are giving birth at an NHS hospital taking part in the trial.

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will randomly choose whether you receive the standard dose or the higher dose of oxytocin. Neither you nor your doctors and midwives will know which dose you receive. The medication is given through a normal intravenous drip into a vein in your arm.

Throughout your labour, midwives and doctors will closely monitor your contractions and your baby's heartbeat, exactly as they do during routine NHS care. Details about your labour and your baby's birth will be recorded from your hospital notes. Taking part will not change the length of your hospital stay. About two weeks after your baby is born, you will be asked to fill in a short questionnaire at home about your birth experience. As a thank-you, you will receive a £5 Amazon voucher once you return it.

Potential risks and benefits

Taking part may not directly benefit you, but the information gathered could help improve care for thousands of mothers in the future. As with any oxytocin drip, contractions can sometimes come too quickly or strongly. However, your maternity team will monitor you and your baby continuously, and they can slow down or stop the drip at any point to keep you both safe. Taking part is entirely your choice, and you can withdraw from the study at any time without your care being affected in any way.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Birmingham Women's and Children's NHS Foundation Trust
City only
Birmingham, England
South Tyneside And Sunderland NHS Foundation Trust
City only
Sunderland, England
Shrewsbury And Telford Hospital NHS Trust
City only
Shrewsbury, England
NHS Greater Glasgow and Clyde
City only
Glasgow, Scotland
North Tees And Hartlepool NHS Foundation Trust
City only
Hartlepool, England
Great Western Hospitals NHS Foundation Trust
Unverified
Swindon, England
Cardiff & Vale University LHB
Unverified
Cardiff, Wales
Manchester University NHS Foundation Trust
Unverified
Manchester, England
NHS Lothian
Unverified
Edinburgh, Scotland
Royal Cornwall Hospitals NHS Trust
Unverified
Truro, England
Burnley General Hospital
Unverified
Burnley, England
Royal Victoria Infirmary
Unverified
Newcastle upon Tyne, England

Common questions

What is oxytocin (Syntocinon)?

Oxytocin is a natural hormone that makes the womb contract during labour. Syntocinon is a man-made version of this hormone that has been used safely in UK hospitals for decades.

Can I still choose my pain relief during labour?

Yes. Taking part in the trial will not affect your pain relief choices. You can still have an epidural, gas and air, or other options just as you normally would.

Can I choose which dose of the medication I get?

No. A computer randomly decides whether you get the standard dose or the higher dose. This makes sure the study results are fair and reliable.

What happens if the contractions become too strong?

Your midwife will monitor your contractions and your baby's heartbeat closely. If contractions become too frequent, the drip can be turned down or stopped immediately.

Do I have to take part?

No. Joining the study is completely voluntary. If you choose not to join, you will receive the standard NHS induction care.

How to find out more

Sara Kenyon

S.kenyon@bham.ac.uk +44 (0)121 414 9063 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.