Results
A total of 57 women participated in the main study (PPH Butterfly II). The clinical results have been published elsewhere.5Six women were approached at the time of the PPH but declined to give verbal consent for the device use with reasons recorded as ‘not interested’ (n=4), ‘did not like idea of new treatment’ (n=1) and ‘insufficient analgesia’ (n=1). Of the remaining 57 women who gave verbal consent at the time of the PPH, all provided postnatal written consent. In the follow-up questionnaire, 89% (n=50) either ‘agreed’ or ‘completely agreed’ that they were happy with the way in which they were recruited to the study (see table 1). Only 4% (n=2) of women were not satisfied with the consent process.
The qualitative study included a total of 51 participants; 12 women with whom the device was used, 12 of their birth partners, 16 recruiting obstetricians and 11 attending midwives. Of the 12 women included in the qualitative study, 50% (n=6) had an epidural in situ at the time of the PPH whilst the other 50% (n=6) had received opiate or inhalational analgesia. Interviews lasted between 7 minutes to 1 hour in length. Key themes identified were the balance of information, trusting relationships, making the decision and a different situation.