The Postpartum Haemorrhage (PPH) Butterfly Work Package 3
Condition: Postpartum Haemorrhage (PPH)
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The Postpartum Haemorrhage (PPH) 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 the investigators to determine if they 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 participants and users. In phase I the investigators will recruit
      "healthy volunteers" i.e. women who have delivered their baby vaginally following Induction
      of labour (IOL) however these women will not be experiencing a PPH. The device is to be
      assessed purely on size, usability and acceptability not for diagnosis or as a treatment
      method. 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 the investigators
      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 administration. Participants will also answer a short
      questionnaire. .
    

Detailed description: 
      The study will involve 5-10 healthy women who deliver their baby vaginally following
      Induction of Labour (IOL). The women will be given a short leaflet regarding the study.
      During their time on the Induction of Labour (IOL) Suite, women will be seen by a member of
      the research team, the research will be discussed with them and they will receive a
      Participant Information Sheet if they desire. The woman will also be shown a short video
      regarding the Postpartum Haemorrhage (PPH)Butterfly which is specifically for members of the
      public. After a discussion of the research, women will be asked to indicate in writing
      whether they may consider participation, whether they do not want to participate, or whether
      they are undecided but are happy to be asked again. Only those women who are considering
      participation, or who are happy to be asked again will be approached post-delivery. All of
      the women can be approached up to 72 hours post-delivery and asked if they wish to
      participate. If a woman has a vaginal delivery, a member of the research team will then
      attend the Delivery Suite, maternity theatre (the woman may have had an instrumental delivery
      in theatre) or the postnatal ward once informed by the midwife caring for her. They will
      clarify with the woman if she wishes to participate. Assuming the woman wishes to
      participate, informed, signed consent will be sought at this point and the device will be
      used, with a speculum examination taking place before and after use of the device.

      If the device is of an incorrect size, then the device size will be changed before repeating
      the process with 5-10 more women. In this way the final recruitment number may be more than
      10 in total.
    

Intervention name(s): The PPH Butterfly
Intervention type(s): Device
Intervention description(s): The PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH
Intervention model: Single Group Assignment
Intervention model description: If the device is not of the correct size, then the device is changed and the recruitment process is repeated until the correct size is obtained.
Masking: None (Open Label)
Primary purpose: Device Feasibility