The main study (OBS UK) is about excess bleeding (post-partum haemorrhage). If your maternity unit is taking part in the sub-study (a smaller study within OBS UK) you may be asked to be part of the study if you have severe bleeding and require blood transfusions during the bleeding or develop problems with blood clotting during the bleeding.

Blood clotting problems can happen in some people at the time of childbirth, which can cause excess bleeding or make the bleeding worse. As part of this study we are collecting information from women and birthing people who have had excess bleeding during childbirth that effects their blood clotting system or means they need blood transfusions during the bleeding.  

If your maternity unit is taking part in the sub-study, as part of the research we are collecting a small amount of extra blood (1-2 tea spoons) from women and birthing people who have blood tests taken during treatment for bleeding during childbirth, according to the usual care pathway for women and birthing people who are bleeding. We are collecting a small extra blood sample from all women and birthing people with severe bleeding as we do not know beforehand who will go on to require blood transfusions during the bleeding or develop problems with blood clotting during the bleeding, and having blood samples from the start of the bleeding is very important for us to understand more about how blood clotting problems develop during bleeding in childbirth.

If a woman or birthing person needs blood transfusions during the bleeding, or has blood clotting problems during the bleeding episode, we will ask their permission to do extra specialised tests on blood samples taken during this time, to look in detail at the blood clotting system. This is so we can learn more about blood clotting systems disorders affecting women and birthing people who bleed during childbirth, including how common they are, how they can be diagnosed, and what is the best way to manage and treat these disorders.

If the bleeding stops without the need for blood transfusions during bleeding, and the blood clotting system remains healthy, any extra blood samples collected will be destroyed and the woman or birthing person will not be asked to take any further part in the study.

If during the bleeding episode there is the need for blood transfusions, or problems are detected in the blood clotting system, after they have recovered the woman or birthing person will be asked by the study team to join the study by asking for their permission to perform specialised tests on the coagulation system on samples stored from their bleeding episode and to share information with the study team.

You will be eligible to take part in the study if you have your baby (or babies) in a maternity unit taking part in the sub-study.

If you decide that you don't want to take any part in the study please let your midwife know. We will indicate this on your medical notes and no extra blood tests will be taken above what is required for your usual care.

If you do decide to be in the study and later decide you do not want to remain in the study, you can pull out without giving a reason at any time up until the end of the study period. If you decide to do this, your information will be removed from the study database and any stored blood samples would be thrown away. This would not affect your treatment in any way. Some time up to 3 years after the end of the study we will remove the information that links any stored results to individuals and so we will not be able to remove your data after this time.

You will be eligible to take part in the study if you have your baby (or babies) in a maternity unit taking part in the sub-study. If you do not opt out of the study and you have severe bleeding in childbirth, a small amount of extra blood (1-2 teaspoons) will be taken on each occasion the time you are having a routine blood test as part of your usual care during the bleeding.

If you require blood transfusions during the bleeding or develop problems with blood clotting during the bleeding, once you have recovered we will ask if you will take part in the study.

If you choose to take part, we will ask you to sign a consent form.

This will show that you agree to be part of the study it will gives the study team your permission for three things:

1. To look at information held in your and your baby's’ medical records to understand details about your pregnancy, your baby’s wellbeing before and after birth, and details of the bleed you had. This information includes details such as your age, the number of babies you have had, how you delivered, the cause of the bleeding and complications with your pregnancy such as pre-eclampsia. We will also look at what treatment you had for bleeding.

2. To look at all the routine blood tests that were taken around the time of your bleed.

3. To perform specialised clotting tests on the extra research blood samples that we have stored.

You won’t have to do anything. The study team will approach you to ask your permission to join the study if you require blood transfusions during the bleeding or develop problems with blood clotting during the bleeding.

 If you never need blood transfusions during the bleeding or develop problems with blood clotting during the bleeding, any study blood samples collected will be destroyed and none of your information will be used in this study.

If the research provides new information about the cause of thin blood in childbirth, this may improve the way we can identify and treat this condition in the future.  If this is the case you may be helping women, birthing people and their babies in the future who have excess bleeding. There will be no benefits to you for taking part in the study.

There will be no extra needles needed for study blood samples to be taken and your treatment will not be altered by being in the study therefore it is very unlikely there are any risks or discomforts from taking part in the study. This study is investigating blood clotting disorders that happen unexpectedly and are linked to childbirth.

This study is not designed to identify a pre-existing blood clotting disorders, which would usually be identified by your doctor outside pregnancy when there is evidence of worrying or unusual bleeding.   

You will not incur any additional expenses if you chose to take part.

You can find out more about how Cardiff University will use your information by

·       asking one of the research team or contacting the OBS UK Trial Management Team (contact details below)

·       viewing the Cardiff University Data Protection Policy: https://www.cardiff.ac.uk/public-information/policies-and-procedures/data-protection

·       contacting the University’s Data Protection Officer by email: inforequest@cardiff.ac.uk or in writing to: Data Protection Officer, Compliance and Risk, University Secretary’s Office, Cardiff University, McKenzie House, 30-36 Newport Road Cardiff CF24 0DE

You can decide to stop taking part in the study at any time and without needing to give a reason. If you wish to withdraw, you can contact the study manager. In order for us to understand the reasons why participants withdraw from the study, we may ask you why you have decided to withdraw. However, you do not have to give any reasons.

It is usual practice to keep the information we have collected to help draw conclusions about the treatment you received.

If you decide to stop taking part, your current and future medical care and the legal rights of you will not be affected in any way.

We hope that the results of the study will improve the care of many patients in the future. At the end of the study, the results will be published in medical journals and presented at medical conferences. This will allow us to tell other doctors and healthcare professionals across the world about the results of the study. 

Information that identifies you will not be presented. We can provide you with information of where to access the published study data. A copy of the results can be sent to you if you would like.

This study has been funded by the National Institute for Health Research (NIHR) Programme and is being managed by Cardiff University.

The study has been approved by an independent NHS Research Ethics Committee (REC) North West - Greater Manchester Central Research Ethics Committee (reference: 23/NW/0242). The committee makes sure that the study is conducted ethically to protect the safety, rights, wellbeing and dignity of the patient in line with the requirements the UK Policy Framework for Health and Social Care Research.

If you experience any side effects as a result of taking part in the study there are no compensation arrangements over and above the usual routes available to any patient treated within the NHS. If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (contact information below). If you remain unhappy and wish to complain formally, please do this through the normal NHS Complaints Procedure.

Thank you for reading this information sheet and considering participation in this study. Our team is experienced and dedicated to doing this important study to the highest international standards, and helping to improve the future care of patients.