The E-Fib Study

The main study (OBS UK) is about heavy bleeding during and after childbirth, known as postpartum haemorrhage (PPH). The E-Fib sub-study (a smaller study within OBS UK) is investigating the best way to treat women and birthing people who develop problems with blood clotting during the bleeding.

If blood clotting problems happen at the time of childbirth, bleeding becomes much worse. Blood clotting problems can occur because a clotting protein called fibrinogen can fall to dangerously low levels, making it harder for the blood to clot and the bleeding to stop. NHS maternity units use different treatments to replace fibrinogen.  We do not know which treatment is the most effective, or whether some patients might respond differently.

The E-Fib study uses existing routine clinical data collected during the OBS UK trial and historical records from women and birthing people who have given birth in Cardiff since 2010, to examine how fibrinogen levels change after different treatments are given. This will help us understand which treatments work best.

Heavy bleeding after childbirth is the most common serious complication of giving birth and can be life-threatening. Knowing the best way to treat blood clotting problems will reduce bleeding and improve care for women and birthing people in the future.

The E-Fib study includes women and birthing people across participating OBS UK maternity units in England, Wales, Scotland and Northern Ireland who experienced PPH, had blood tests confirming their fibrinogen levels were very low, and received treatment to correct this as part of their care. Additionally, the study includes pseudonymised data from women and birthing people who gave birth in Cardiff from 2010 onwards and met these criteria.

The trial will use information that is routinely collected by the NHS about labour and childbirth. Women and birthing people will not need to provide written consent to be involved.

Information about how to ‘opt in’ or ‘opt out’ of your data being used for this research is available here.

If you have given birth in Wales, 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.

At the end of the study, results will be published in medical journals and presented at conferences. No information that identifies individual women or birthing people will be included.

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