Emergency verbal consent for intrapartum research: a grounded theory
study to explore its acceptability in a clinical trial of a novel device
to treat postpartum haemorrhage
Abstract
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)