Title: The postpartum haemorrhage (PPH) Butterfly: clinical testing and commercial development
Funder: Department of Health and Social Care

Abstract: The design and overall study plan are outlined in the diagrams in the appendix. The development of this new device was made possible by a previous i4i grant (II-LA-0712-20007). In this, important feedback regarding the device and study design was received from user and consumer focus groups, University of Liverpool academics, and from the British Maternal & Fetal Medicine Society's Intrapartum Clinical Study Group. This has been invaluable, and led to numerous improvements. This process for consumer and user engagement will continue through this proposed study. At the start of the project, it may first be necessary to optimise the design of the PPH Butterfly following its first in human testing (funded by a previous grant). This could involve minor modifications to the design or dimensions so as to improve its efficacy or commercial potential. These computer-aided design changes would be undertaken by Interplex, whilst the manufacture of the injection moulds and the moulding would be conducted by ProtoLabs Ltd, who have undertaken the injection moulding of current design of the device. The finalised PPH Butterfly devices would be used in the proposed observational study. Although there is significant awareness of, and enthusiasm for the PPH Butterfly amongst staff at Liverpool Women's Hospital, it is a new medical device that has not yet been used in clinical practice. It will therefore be necessary to develop and implement a multi-resource training package, encompassing both practical elements and digital media resources. This training will be used and tested on the doctors recruiting women to the observational study at Liverpool Women's Hospital, and will be ongoing during the study due to the yearly rotation of doctors. The package will be refined as it is being used. One output of this study will be a fully evaluated training package, with the scope for it to be utilised on a wider scale as necessary, dependent upon future progress of the device. Following staff training, a mixed-methods observational study will be conducted, using the device in 118 postnatal women with PPH as part of the initial treatment of their haemorrhage. This will allow an evaluation of the PPH Butterfly by clinicians, both in its efficacy and its usability. The primary outcome will be an estimated total blood loss of over 1000mls. The data for the recruited women will be compared to that of a matched historical cohort. During the course of this observational feasibility study, a qualitative assessment of the device will be conducted through interviews with the recruited women, device users and midwife observers. This will inform the future device development and direction of research. The comparison with the matched historical cohort will also be used for the purpose of a health economics analysis. This will model the device's potential cost-effectiveness, and inform a budget impact analysis to examine the total NHS costs if the PPH Butterfly was rolled out nationally. It is projected that after the completion of the above work, the PPH Butterfly will be at a stage whereby it can be CE marked. We will work with Pelican Feminine Healthcare to commission a commercialisation analysis. This will include an assessment of large scale manufacturing costs, the size of the potential market, and the production of a business case using estimated market size, costs, training needs and profits. The results of this study will be used as feasibility data for a large scale cluster randomised trial which will formally assess the effectiveness of the device with a concurrent full economic evaluation. This will be the subject of a future application to NIHR.

Lay abstract: Post Partum Haemorrhage (PPH) 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 cause contraction. 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 i4i programme has funded the design and initial human testing of the device. In this application, 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.

Research activity codes: 5.3 MEDICAL DEVICES;6.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH