Heavy bleeding during and after birth is the most common problem of childbirth. We have created a new way of managing heavy bleeding during and after childbirth (called the OBS UK care bundle). This care bundle helps to recognise bleeding early and to standardise the treatment of heavy bleeding during childbirth. When this package of care was introduced in Wales, we found that the number of women and birthing people who needed a blood transfusion was reduced and that fewer had very large bleeds. We now need to run this larger study to see whether the improvements seen in Wales can be seen across the wider NHS. If the OBS UK care bundle is shown to make a big improvement to outcomes, then it may advise the new UK standard guidance for dealing with heavy bleeding during and after childbirth.

Everyone will be given usual NHS care for bleeding during childbirth. As well as this, the OBS UK care bundle adds:

1) Assessment of everyone’s bleeding risk before and during labour,

2) Real-time measurement of blood loss after all births,

3) A consistent method to involving more senior doctors and midwives,

4) A bedside test to quickly identify and treat abnormal blood clotting.

Quality improvement systems will be used to make sure all training is standardised and that the OBS care bundle is being implemented correctly.

40 maternity units across England, Wales, Scotland and Northern Ireland are involved in the trial. To find out which maternity units are involved, please Click here

The OBS UK care bundle is already being used in Wales. In four of these maternity units we will observe how the OBS UK care bundle is working in practice. The study will not be collecting routine maternity data from these units. Click here to find out more.

At the start of the study all maternity staff will be providing usual care to everyone giving birth, following current NHS standards. We will provide training for maternity staff so that they can safely use the OBS UK care bundle in addition to usual NHS care. After the 9-month training period, all maternity staff will be providing usual NHS care and the OBS UK care bundle to all women and birthing people.

The timing of when your maternity unit will start the training about the OBS UK care bundle will be staggered over 18 months. Whether you receive the usual care or OBS UK care bundle will depend on when your maternity unit is assigned to start the training.

You will not need to provide written consent to be involved in the main trial. The trial will use information that is routinely collected by the NHS about your labour and birth and your baby. In England this information will all be linked together and de-identified by NHS England. The linked dataset will be securely transferred and stored in the National Safe Haven in Edinburgh Scotland..

Further information for sites in Scotland and Northern Ireland is available here.

This information will be anonymised once it is linked and it will be deleted once the trial has finished.

This information is vital to fully understand how the OBS UK care bundle affects women, birthing people and their partners. To find out more about data confidentiality click here.

You, and your partner, may also be invited to take part in questionnaires and/or interviews. These are looking into the psychological and financial effects of the OBS UK care bundle and how the clinical team cared for you during childbirth. If you are eligible and interested in being involved, your local maternity team will provide you with further information. Find out more.

An important part of the study is that all women and people giving birth in a participating maternity unit are treated the same. The care provided by your maternity unit will either be usual NHS care or the OBS UK care bundle, which we know is safe.

National data ‘opt out’

If you are having your baby (or babies) in England, and you do not want your data to be used for this trial, you will need to contact the national data opt-out.

This is a service that allows you to ‘opt out’ of all your health information being used for all future research and planning, (not just for this study).

If you ‘opt out’ of your data being used after it has been collected and processed, unfortunately it cannot be erased, as it will have already been anonymised.

For more information or to ‘opt out’ of data collection go to: https://www.nhs.uk/your-nhs-data-matters/

OBS UK specific data ‘opt out’

If you are giving birth in England or Scotland you can tell us if you don’t want your birth data included in this study. To ‘opt out’ tell your midwife or your local maternity research team. If you do not know how to contact them, email our study team at OBSUK@cardiff.ac.uk and we can help you.

How can I 'opt in' to having my health information used for research and planning if I have previously 'opted out’?

If you have previously 'opted out' of having all your health information used for all research and planning in England and you have changed your mind, then you will need to 'opt in'.

The process of 'opting in' is clearly set out on the 'Your NHS data matters' website.

If you 'opt in' then all your health information will be able to be used for all future research and planning including this trial.

For more information about data confidentiality in England, Scotland and Northern Ireland maternity units participating in the study, click here.

Questionnaires and interviews

You do not have to take part in the questionnaires or interviews. Participation is entirely voluntary and you are free to refuse to take part or withdraw at any time without having to give a reason. If you do decide not to take part or to withdraw, this will not affect the care you or your partner receives.

Who is running this study?

The trial is being led by Professor Peter Collins and Dr Sarah Bell from Cardiff University and Cardiff and Vale University Health Board.

The trial is sponsored by the Cardiff University.

The trial is being co-ordinated by the Centre for Trials Research at Cardiff University.

The trial is funded by the National Institute for Health and Care Research’s Health and Social Care Delivery Research Programme (Project Reference 152057).

What is bleeding during and after childbirth? – a doctor’s perspective

What is it like to experience bleeding after childbirth – patient perspectives