Objective: To understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage post-partum haemorrhage (PPH). Design: Grounded Theory. Setting: Tertiary facility in the North-West of England, UK. Sample: We used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives. Methods: Semi-structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique. Results: Most women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency. Conclusions: This is the first study to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and consenters require adequate training. (197/200)

Objective To understand the maternity experiences of women living in areas of high ethnic diversity and social deprivation. Design An anonymous self-reported on-line survey incorporating demographic, clinical outcome and validated tool (Experience of Maternity Care) questions, and free text responses. Setting A large urban NHS Trust in Northwest England Sample Postnatal women, living in eight postcodes identified as areas of high socio-economic deprivation and ethnic diversity. Methods Quantitative data was collected and analysed using appropriate statistics. Free text responses were coded and thematically analysed. Main outcome measures Experience of Maternity Care scores and free text themes. Results Sixty-four percent of the sample identified as from an ethnic minority. Black women (42/68, 62%) were more likely (p=0.003) to attend their first antenatal visit at 12 or more weeks’ gestation compared to White (69/87, 79%) or Asian women (127/150, 85%). Black (p=0.004) and multiparous (p=0.012) women were more likely to report a positive postnatal experience. Most women were positive about the care they received overall, but responses to specific questions revealed concerns related to some aspects. Most (82%) respondents did not mind being looked after during labour and birth by midwives or doctors they had not met before. Themes from free text responses included continuity of care, respectful care, communication, early labour care and access to timely pain relief. Conclusions Using a targeted approach ensured an ethnically diverse sample and despite overall positive experiences of maternity care, negative experiences reflect similar themes previously identified within UK maternity care.

Objective: To assess the acceptability, safety and efficacy of the PPH Butterfly, a new uterine compression device, in women with postpartum haemorrhage (PPH). Design: A phase two clinical device trial using matched historical controls, with accompanying grounded theory study. Setting: UK university consultant obstetric unit. Population: women with PPH after vaginal birth unresponsive to initial oxytocin therapy. Outcomes were compared to historical controls matched on blood loss, parity and type of birth. Methods: after oral consent, trained staff used the device in additional to normal care. Main Outcome Measures: The primary outcome was additional blood loss >1000mls. Qualitative interviews assessed device feasibility and acceptability. Results: Of the 57 recruits, two-thirds were primiparous and almost half had undergone operative birth. Two percent of recruited women had additional blood loss of over 1000mls compared to 8% of 113 controls (adjusted odds ratio 0.13, 95% CI (0.02 to 1.09)). Women treated with the device received significantly more additional treatments and had higher rates of exclusive breast-feeding at discharge. There were no serious adverse events related to the device. In 47 interviews, participants, birth partners, clinicians and attending midwives viewed the device positively. Clinicians found it useful to stop blood loss and diagnose the source of bleeding. Conclusions: the PPH Butterfly is acceptable and may have clinical benefits: it is a promising device for PPH management. Funding: National Institute for Health Research invention for innovation (i4i) program (II-LA-0715-200008) Keywords: postpartum haemorrhage, childbirth, oxytocin, third stage of labour, uterine compression. Registration: prospective ISRCTN (15452399); www.isrctn.com/ISRCTN15452399