Post-Partum Haemorrhage (PPH) Butterfly
Post-partum haemorrhage (PPH) is a common obstetric emergency and accounts for over 20% of all maternal deaths globally. The most common cause is failure of the uterus to contract. So the usual first treatment is to repeatedly give drugs to force a contraction.
If these drugs fail, then the woman is usually taken to an operating theatre to identify the source of the bleeding and to use physical methods to stop the bleeding, usually sutures or a balloon inside the uterus. These two second-line methods for PPH management are very uncomfortable and difficult to perform without an anaesthetic. A device that could simply and painlessly perform these functions would be a major advance.
Bimanual compression is the easiest form of uterine compression but it involves inserting a clenched fist into the vagina and squeezing the uterus between it and the other hand placed on the stomach wall.
The PPH Butterfly provides a smooth, slim replacement for a vaginal fist. The device comprises a perforated platform with a folding handle originating from either end. The handles can be folded in line with the platform so as to make a streamlined device, allowing smooth insertion.
Once inserted, the handles are unfolded, moving the platform from a longitudinal to horizontal position. The handles interlock so as to provide stability for use. The handle is purposefully large so as to prevent over-insertion, whilst at the same time protecting the perineum, ensuring that it does not cause or extend perineal trauma. It is possible for the handle of the device to be lodged into the bed (if the woman is in a dorsal position on a bed) so as to provide additional stabilisation. This allows the device to be operated using one hand only, which would be externally placed on the uterus, through the abdominal wall. Upon sliding back one handle, the device returns to its original folded state, allowing the device to be removed without discomfort or trauma.
Videos
Further details in relation to the PPH Butterfly can be found in the following video clips, presented by the device’s inventor Professor Andrew Weeks.
The first video is specifically for members of the public to view.
A separate video clip has also been developed for clinical professionals to access more information about the PPH Butterfly.
History of the device
The PPH Butterfly was invented by Professor Andrew Weeks, with the intellectual property held by the University of Liverpool.
Following a grant from the NIHR Invention for Innovation (i4i) funding stream, prototypes were designed and developed with the Clinical Engineering Department of the University of Liverpool.
A collaborative relationship was established with Pelican Feminine Healthcare Ltd (Cardiff, UK) early in the project. Their input involved an advisory role as part of a twice-yearly Scientific Advisory Group, and optimising the computer-aided design for injection moulding through their design team at Interplex Select Moulds (High Wycombe, UK).
The final injection moulding of the model for in vivo testing was undertaken by Proto Labs Ltd (Telford, UK) with assistance from Plastribution Ltd (Ashby-de-la-Zouch, UK).
Two studies have been completed testing this device, both funded by the NIHR and sponsored by the University of Liverpool.
The study team is now progressing to a full randomised trial to explore whether adding the device to the standard management results in improved outcomes for the women.