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Clinical research

Two studies have been completed testing this device, both funded by the NIHR Invention for Innovation (i4i) programme and sponsored by the University of Liverpool:

 

  1. The first study was conducted on healthy women at Liverpool Women’s Hospital (lwh.nhs.uk), the largest specialist women’s hospital in the UK, who had just given birth to assess the correct size of the device. It also evaluated its acceptability and usability. The positive findings allowed the study to progress to a full clinical study.
  2. A second study conducted through 2018 explored the use of the device in the management of PPH. 57 women with active bleeding that had not stopped with first-line drugs were treated with the device. Only one woman continued to bleed after the device was inserted, and no harm was caused. Clinicians found it useful as a way of stopping blood loss and as an aid to diagnose the source of bleeding. All women said they would be happy for the device to be used again in any future bleeds during birth. 93% of clinicians wanted it to be available for future use.

The study team are now progressing to a full randomised trial to explore whether adding the device to the standard management results in improved outcomes for postpartum women.

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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:

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.