Phase I Clinical testing of the Postpartum Haemorrhage Butterfly
Research type
Research Study
Full title
The PPH Butterfly: phase I of a study of a new device to manage postpartum haemorrhage.
IRAS ID
168635
Contact name
Andrew D Weeks
Contact email
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
The PPH (Postpartum Haemorrhage) Butterfly is a simple, low-cost device which has been developed as a treatment method for PPH. It will be used to stop the bleeding through compression of the uterus of women having a PPH. It will be markedly easier to undertake than traditional bimanual compression, whilst also being significantly more acceptable to women themselves. Use of the PPH Butterfly will provide an alternative management option for PPH and in some cases should avoid the need for women to have to go to theatre for treatment. This research will allow us to determine if we have the optimum size and shape of the device, that it will operate as intended when compressing the uterus, and to gauge its acceptability to women and users. In phase I we will recruit women who have delivered their baby vaginally following Induction of Labour for being overdue. Following the delivery participants will be invited to have the PPH Butterfly inserted vaginally for an average of 2 minutes. It is through this that we will assess the suitability of the device in its current design, when it is in practice. The clinician who operates the device will complete a Likert scale questionnaire along with some open questions following each use. Participants will also answer a short questionnaire. The study overall is funded by the NIHR Invention for Innovation programme, and this part of the study will last up to 6 months. All the women will be recruited at Liverpool Women's Hospital NHS Foundation Trust.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1464
Date of REC Opinion
31 Dec 2014
REC opinion
Further Information Favourable Opinion