Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals

摘要: Recruiting and consenting women to peripartum trials can be challenging as the concerned may anxious, in pain, exhausted; there also limited time for discussion decision-making occur. To address these potential difficulties, we undertook a qualitative evaluation of internal pilot trial (Got-it) involving who had retained placenta (RP). We explored experiences views staff about information consent pathway used within pilot, order provide recommendations use future recruitment emergency situations. In-depth interviews were undertaken with (n = 27) participating (n = 22). Interviews analysed thematically. The accounts compared identify differences similarities their procedures. Women regarded having been straightforward facilitated by simplified (verbal written) summaries information. Both parties, however, conveyed discordant whether fully informed obtained. These perspectives appeared arise from different factors considerations impinging on women at recruitment. While placed emphasis on promoting understanding situation RP imparting clear succinct ways, highlighted experiential realities pre- post-birthing situations, how led quick decisions being made without full engagement risks participation. facilitate consent, suggested that should given during antenatal period, and, doing so, articulated rights-based discourse. Staff, voiced opposition this approach emphasising duty care all pregnant women, raising concerns causing undue distress majority individuals would not subsequently develop RP. By drawing upon involved same have shown they operate ethical paradigms. In argue benefits multiple when developing pathways (peripartum) trials. ISCRTN 88609453 .