Professor Andrew Weeks: The post partum haemorrhage (PPH) Butterfly – clinical testing and commercial development

Post Partum Haemorrhage (PPH), loss of blood after childbirth, is a common maternity emergency affecting 40,000 women across the UK each year. The incidence and severity of PPH is increasing and novel treatments are urgently needed.

The most common cause is failure of the womb to contract, and drugs are first administered to stimulate the womb to contract. If these fail, then the woman is taken into an operating theatre to find the source of the bleeding, and physical methods used to stop the bleeding under anaesthetic. A device that could simply ‘turn off the tap’, without the need for surgical intervention, would be a major advance in PPH management.

The PPH Butterfly is a completely new device. It is placed into the birth canal when bleeding starts and allows the doctor or midwife to stop the bleeding by squeezing the womb against it. It also detects whether the bleeding is coming from the womb or vaginal tears.

The National Institute for Health Research (NIHR) Inventions for Innovation (i4i) programme has funded the design and initial human testing of the device.

The study is being led by Andrew Weeks, Professor of International Maternal Health Care at the University of Liverpool, and Director of the Sanyu Research Unit.

The design will first be optimised for commercial production with assistance from our commercial partner. Simultaneously, a training package will be developed for staff at the recruiting hospital, and its effectiveness assessed in an observational study of 118 women with PPH at Liverpool Women’s Hospital. Interviews will be conducted with staff and recruited women to assess the device’s acceptability and usability. A health economics analysis will look at the costs of a PPH when managed traditionally, and when treated by the PPH Butterfly. Cost and clinical outcome data from recruited women will be compared with that of a historical cohort.

Following successful completion of the study, the device will be submitted for CE marking and a commercial review undertaken to assess the market potential of the device.

During the development of the stage 2 funding application, Professor Weeks and his team sought advice from the NIHR Research Design Service North West (RDS NW). On approaching the RDS NW the proposal was well worked up and as such the RDS NW provided a critical read of the proposal. Following the critical read, advice was provided on the statistical aspects of the proposal. The RDS NW also helped respond to reviewer’s comments following the project being offered conditional funding.

The RDS NW provides an advice service that covers all aspects of developing a research funding application in applied health and social care. From advice on formulating a research question, structuring and designing the proposal, research methods, public involvement to a critical reads of the proposal. For full details of the advice offered by the RDS NW visit the RDS NW website here.

This study was funded by the NIHR Invention for Innovation (i4i) programme.

The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.