Objective Postpartum haemorrhage (PPH) is a significant cause of maternal morbidity and mortality. The most common cause is an inability of the uterus to contract adequately after childbirth. In bimanual compression (BMC), one hand is placed within the vagina and the other hand is on the abdominal wall to compress the uterus. It is effective, but very uncomfortable for the woman. We designed a device that could replicate BMC without inserting a hand vaginally, therefore being less invasive. It could also help in diagnosing the source of the bleeding.
Design Mixed methods, combining an iterative design process with input from clinicians in simulations, and focus groups of clinicians and consumers.
Setting Department of Women's and Children's Health and Department of Medical Physics and Clinical Engineering, University of Liverpool, UK.
Methods A multidisciplinary team developed the design, using an obstetric manikin. Clinician and consumer groups also gave input on the concept and design. A healthcare product company and prototype manufacturer provided input into strategy, design and manufacture.
Results The PPH Butterfly is a single piece, plastic medical device that replicates BMC. It is designed to be easy to use and low-cost and allows for smooth insertion and removal. It is acceptable to clinicians and consumers and performs well in tests.
Conclusions This is the first device designed to replicate BMC while being less invasive. It could potentially be an effective form of PPH management, while also diagnosing the source of the bleeding. The device will now be tested in humans.
- Postpartum Haemorrhage
- Bimanual Compression
- PPH Butterfly
- Uterine Atony
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Correction notice This article has been corrected since it was published Online First. Figures 9-13 were published in the wrong order. This has now been amended.
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Contributors The initial PPH Butterfly concept and design was developed by AW, PW and JP. Subsequent design meetings were attended by CC and DL. CC wrote the first draft of the manuscript, which was subsequently revised by AW. All authors approved the final version before submission.
Funding The very first designs of the device were not externally funded. Subsequent funding was received from the National Institute for Health Research (NIHR) Invention for Innovation funding stream II-LA-0712-20007. This funding was over a period of 36 months. Additional funding came from the Sir Halley Stewart Trust for the manikin and from the University of Libya for NA PhD. Additional support came from the Department of Medical Physics and Clinical Engineering who offered their services at reduced cost.
Disclaimer The views expressed in this paper are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests AW and JP are named as inventors of the device and would receive a proportion of any loyalties generated.
Ethics approval Development of the PPH Butterfly did not involve humans and so formal ethical approval was not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available from the study, other than the device technical file which is currently held by the University of Liverpool.
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