PPH Butterfly Study (II): Clinical Testing and Commercialisation
Research type
Research Study
Full title
An open label phase II unrandomised clinical trial employing the Post-Partum Haemorrhage (PPH) Butterfly to test management of PPH with this innovative device, with historical controls.
IRAS ID
213940
Contact name
Andrew Weeks
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 2 months, 2 days
Research summary
The CI will undertake this single site study,an open label phase II non-randomised clinical trial to employ the Post-Partum Haemorrhage (PPH) Butterfly to test management of PPH with this innovative device. Following the clinical testing of the device the research study, and its commercial partner, will seek to commercialise the product.The PPH (Postpartum Haemorrhage)Butterfly is a simple, low cost device which has been developed at the University of Liverpool for management of heavy bleeding immediately after childbirth (PPH). The research question is relevant to women in that if the device is successful in “turning off the tap“ there will be direct tangible benefits to the women and may avoid the need for women to undergo surgical procedures in theatre for treatment. We need to test the device in a clinical trial on 118 women experiencing a PPH to assess its efficacy. The device will be used to stop the bleeding through compression of the uterus. This will be markedly less invasive to undertake than traditional bimanual compression. Use of the PPH Butterfly will provide an alternative management option for PPH. The recruitment period will last for 14 months.\n\nThe CI would like to use 236 historical controls (2:1) to assess the difference in clinical outcomes of women who experienced a PPH and who were treated under the Liverpool Women’s Hospital standard clincial treatment pathway for PPH (controls)with those women who were treated with the PPH Butterfly. \n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0373
Date of REC Opinion
11 Aug 2017
REC opinion
Further Information Favourable Opinion