Title: The PPH Butterfly: development and phase 1 studies of a new device to manage postpartum haemorrhage.
Funder: Department of Health (England)

Abstract: Experimental plan Workpackage 1 (months 1- 9 ): a series of PPH Butterfly prototypes will be developed in the Clinical Engineering workshops. An anatomically correct postpartum pelvic mannequin will also be developed that mimics the anatomy in a woman with PPH immediately following childbirth. A model is already available from Limbs and Things Ltd, but our tests have found it to be poorly representative of real life. The basic model will therefore be adapted, and an atonic uterus containing an internal pressure assessor incorporated. This will allow the effectiveness of uterine compression to be measured. The pressure change in the intrauterine pressure sensor will be transmitted to a piezoelectric transducer that produces an electric signal. The electric signal will be amplified to allow it to be detected by a datalogger, which then interfaces to a conventional PC. The datalogger software produces a graphical display of the pressure in the uterus, as a function of time (see appendix for examples). From this, the maximum pressure generated as well as the area under the curve over specified times can be calculated. Successive butterfly prototypes and mannequins will be assessed by focus groups of clinicians (doctors and midwives) and consumers until designs are produced that are effective and acceptable. Data from this phase will be filed with view to CE marking of the device. Workpackage 2 (months 9 - 15): This will involve in vitro testing of the butterfly prototype by a larger group of doctors and midwives on the new mannequin. The intrauterine pressure sensors will enable the research team to accurately assess the amount of pressure exerted during butterfly assisted compression and compare it to that from bimanual compression. A small pilot study will determine the normal intrauterine pressure 'area under the curve' over 5 minutes, and a randomised cross-over study will be conducted, powered to detect a clinically important improvement in AUC based on baseline data from the initial tests. Workpackage 3 (months 15 - 27): After any further changes to the Butterfly, the device file will be submitted to the MHRA for approval for use in a clinical trial. The clinical trial will initially take place in a cohort of 10 women having normal vaginal deliveries and Cesarean sections. The outcomes will be assessed using mixed methods research - semi-structured interviews with the clinicians and women as well as maternal pain and satisfaction scores. If satisfactorily completed, the device will be tested on a cohort of women with bleeding after childbirth, and assessed using the same methods along with blood loss. Workpackage 4 (months 27- 30): The last 3 months will include disseminating and writing up of the research. The outcomes including the findings, implications and recommendations of the study will communicated at local, national and international meetings as well as in high impact publications. After successful completion of the above study, funding will be sought to compare the device to standard care in a randomised controlled trial. The butterfly will be tested as a first line adjunct to the standard PPH treatment. The study will be supervised by a University team with a wealth of clinical and research experience. Previous projects have been delivered on time and within budget. The project team will include 3 Prof.s, a post-doctoral medical engineer, a post-doctoral research manager, an industrial physicist, a midwife, a self funded PhD student and a qualified ethicist to provide the necessary time and drive for the project.


Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH