Clinical algorithm leads to international changes in the treatment of postpartum haemorrhage
Development of new treatment protocols leads to reduction in massive bleeding and transfusion after childbirth across Wales, and changes to national and international clinical practice guidelines.
Postpartum haemorrhage (PPH) is the leading cause of maternal mortality worldwide. The condition has doubled in the UK in the last 15 years, affecting around 5300 women and resulting in more than 750 intensive care admissions per year.
Between 2014 and 2016, it caused 31 maternal deaths across the UK. The bleeding is caused by obstetric complications after delivering a baby and is often made worse by blood clotting abnormalities, including those associated with low levels of the clotting factor fibrinogen.
PPH is defined as blood loss of over 500ml in the first 24 hours after childbirth, and massive PPH is defined as losing over 2500ml. Low levels of the protein fibrinogen recorded in blood plasma early during a haemorrhage can help predict the likelihood of bleeding progressing from a moderate to a massive PPH. However, lab testing a mother’s blood for this takes between 60-90 minutes to return results, which is too slow to be useful in an emergency. Before 2013, treatment of PPH was automatically based on infusion of fresh frozen plasma (FFP) and platelets, with fibrinogen only recommended if bleeding continued.
Research leads to development of new care package for PPH
Between 2008 and 2018 a Cardiff University team lead by Professor Peter Collins developed research to produce a clinical algorithm, designed to rapidly replace fibrinogen based on point-of-care testing.
The team then developed a 4-step care package, rolled out across Wales, which involves making a risk assessment of mothers during labour and closely monitoring blood loss, alongside the use of the algorithm to identify mothers who may need additional measures to stop bleeding.
The research and care package were developed alongside and rolled out in partnership with the University’s excellent NHS colleagues across South Wales, without whom the work could not have been made possible. In particular, obstetric anaesthetists Rachel Collis, Lucy de Lloyd and Sarah Bell alongside countless other midwives, consultants and junior doctors were instrumental in the development of the package and its subsequent use in Wales and beyond.
Challenging the existing approach
The care package, developed between 2008 and 2018, focuses on the following areas:
- Accurate quantification of blood loss during delivery – Cardiff University research showed that visual estimation of blood loss could misestimate by up to 1500ml. The university team and collaborators created a new, more accurate method of estimating blood loss that could be carried out in real time by junior staff.
- Rapid point-of-care testing for bleeding biomarkers – the university team and collaborators embedded the use of a 10-minute point-of-care test for fibrinogen levels, which helped to identify women who would later need blood transfusion and surgical procedures to control bleeding.
- Appropriate use of fibrinogen and other clotting factors – in the absence of point-of-care fibrinogen testing, many women were automatically given early transfusions of fresh frozen plasma (FFP). The research, using the new 10-minute test, discovered the point at which intervention with transfusion and replacement fibrinogen was necessary, leading to fewer unnecessary transfusions.
The new care package provides clearer, standardised methods for monitoring blood loss, reducing the incidence of massive and life-threatening PPH and the need for blood transfusion whilst preventing infusion of unnecessary blood products.
This new treatment approach, when implemented across Cardiff, resulted in an 83% reduction in massive PPH and reduced the number of mothers needing a blood transfusion by 32%.
Eighteen months after the end of the pilot scheme, the overall incidence of massive PPH, blood transfusion over 5 units or FFP transfusion was 2.8/1000 births, compared to 6/1000 births elsewhere in the UK.
Following this success, the new care package was implemented in maternity units across Wales as part of the Obstetric Bleeding Strategy for Wales (OBS Cymru), leading to a 23% reduction in massive haemorrhage across the country and a 29% reduction in progression from early to massive bleeding.
More recently, the package has been rolled out to Scotland and England, and the research findings have also underpinned changes to international guidelines used to inform clinical management of maternal bleeding globally.
- The Cardiff University research findings also influenced clinical guidelines, and in turn, clinical practice in Europe, Australia and New Zealand
- The importance of OBS Cymru was recognised by the MediWales Innovation awards Efficiency through Technology Programme (December 2017), the NHS Wales Awards for Promoting Clinical Research and Application to Practice (September 2018), the NHS Wales Midwifery and Maternity awards for OBS Cymru champion midwives (2019) and the British Medical Journal Innovation in Quality Improvement Category awards (June 2019).
- The findings of the Cardiff University research have changed national and international guidelines, including those from the British Society of Haematology, the Royal College of Obstetrics and Gynaecology, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, the International Society on Thrombosis and Haemostasis and the German, Austrian and Swiss Societies of Gynaecology and Obstetrics.