The Clinical Study of the PPH Butterfly
The study is taking place at Liverpool Women’s Hospital (www.lwh.nhs.uk), the largest specialist women’s hospital in the UK. The device was invented by one of the hospital’s consultant obstetricians, Professor Andrew Weeks.
What will the study involve?
We are looking to recruit 118 women to the study. These will be women who give birth to their babies at the Liverpool Women’s Hospital and have a post-partum haemorrhage (PPH). These women will receive all of the standard PPH treatment but will also have the womb squeezed using the device. In this way we will assess whether the device is effective at stopping the bleeding.
We are hoping to start recruiting to the study in late 2017. Some women will be approached to take part whilst attending the Antenatal Clinic where they will be given further information and an opportunity to ask further questions. Others will be approached at the time when they are bleeding, but only if there is time to do this. All women will be asked for permission either verbally or in writing before the device can be used.
On the following day the research midwife will return to check on how she is, and ask about her experience of the PPH Butterfly device. You and your birth partner may also be asked whether you want to take part in more detailed interviews to explore your experience of taking part.
Benefits to taking part
If the PPH Butterfly works as anticipated, then it would stop bleeding very quickly. This might prevent the need for participants to have iron tablets, a blood transfusion or the need to go to the operating theatre.
What are the possible disadvantages and risks of taking part?
The PPH Butterfly is a new device, and we do not think there are any problems with using it. We have tested the device for size and fit on a number of healthy volunteers and there were no problems with it in any of the study participants. Some discomfort may be experienced (as with any internal examination) but participants will be offered pain relief whilst the device is used. Should anything untoward occur then doctors will be on hand to deal with this.
The safety of those taking part is very important to us. If you have any concerns about your health after you have left the hospital, you should consult your GP. We will write to the GPs of all those taking part to ask them to report any events which may have been caused by the device. Others may see their midwife or come straight back to the Women’s Hospital (LWH) if they develop problems. A confidential system will be set up within LWH which will record if a participant is seen at the LWH within 6 weeks of the device being used. These measures will make sure that we don’t miss any complications caused by the PPH Butterfly.
We are interested in comparing the clinical outcomes of women treated with the PPH Butterfly device to those of women who did not have the device used on them. To do this we will look at the stored records of matched women who gave birth at the LWH 2 years ago and who had a PPH.
In order to look at historical data the research team has to work under special terms and conditions set by the Confidential Advisory Group (CAG), part of the Health Research Authority. This is because we did not ask for permission from patients directly to look at their data for this study. So, if you had a baby at Liverpool Women’s Hospital during the last 4 years and do not wish for your patient record to be accessed, please email the research team using the contact details below and your data will not be used in the study.
Will taking part in the study be kept confidential?
Yes. The research team follows strict ethical and legal practice and all information about participants will be handled in confidence. In order for the research regulators to be assured of research standards they may undertake monitoring or auditing visits, and we are legally obliged to share data with them should they ask for it.
Results of the study
The results of the research will be published in academic papers and journals (not giving any personal details of participants). Lay copies together with scientific reports will be posted on this website after the trial has completed in 2019.
What will happen with the results of the study?
The results of the study will be used to inform further development of the PPH Butterfly device prior to a final working model being manufactured for use to treat women with bleeding after childbirth.
Who is funding the research?
The research is funded by the National Institute for Health Research, Invention for Innovation programme.
Who has reviewed the study?
All research in the NHS is examined by an independent group of people called a Research Ethics Committee in order to protect your interests. This study has been reviewed by Liverpool Central Research Ethics Committee (17/NW/0383). It has also been passed by:
- The University of Liverpool Sponsorship committee
- The Medicines and Healthcare products Regulatory Agency (MHRA)
- The Health Research Authority
- The Confidential Advisory Group
- The PPH Butterfly Independent Trial Steering Committee
- The PPH Butterfly Independent Safety and Data Monitoring Committee
- The PPH Butterfly Public Engagement Panel
We have only been able to provide a summary of the research details on this site. If you would like further more detailed information on this study please contact the Sanyu Research Unit on:
Phone: 0151 795 9815 or Text 07754 466 156
These contact details may also be used should you wish to register your objection to the use of your patient identifiable data within this study.