Interpretation
This study followed RCOG guidance for taking consent for research in
acute situations.3 The process of taking verbal
consent with subsequent written consent and was found to be acceptable
to women and birth partners. This reflects the information-giving
process for taking verbal consent for clinical procedures, despite the
fact that many obstetricians perceived that more detail was required for
research. Women in this study however, believed they had been provided
with adequate information with which to make a decision, even though
there was not perfect recall of the exact information given. This
differs from other studies where some women did not recall their
involvement in research.4 This may be due in part to
the fact that half the women in this study chose epidural for pain
relief and therefore may not have experienced disorientation due to
systemic analgesia. However, even women who chose opioid methods of
analgesia were able to recall giving consent, if not the detail. The
balance of information given was important; women did not want to be
overwhelmed with information, rather they preferred to receive the key
points on which to base their decision, reflecting the findings of
others.12,13 In practice, information requirements are
likely to vary between women, dependent on their individualised needs
and situation at the time.2
The information needs of women appeared to be dependent on the evolving
situation, with women in this study mostly not wanting prior information
about the study. Whilst it is recognised that women do seek out
information about pregnancy and birth,14 this may
relate to normal process, rather than complications of birth or
research. Women may be employing this as a strategy to preserve their
plans for normality in labour and birth, with consideration of
alternatives only when necessary. A systematic qualitative review by
Downe (15)15 suggests that whilst women do not want
interventions, they do want a safe birth; this may explain how and when
women choose to interact with information and choices for care. Birth
partners felt that women should have information in advance; however,
they were less aware of potential complications of labour and birth.
In determining study participation, the relationship and degree of trust
between the woman and the obstetrician seeking consent was paramount,
reflecting previous findings (4, 13, 16, 17). In this study
obstetricians also agreed the relationship was important and felt more
comfortable discussing the study with a woman they had built a
relationship with, rather than someone they had just met.
Communication was an important element in the consent process (9) and
the verbal nature of the information delivery may have enabled the key
points of the intervention to be highlighted in a concise and
understandable way. However, this is dependent on the skills and
equipoise of the clinician to ensure balanced information is given.
Self-perceived clinical competence, team support and time factors are
all elements which can affect information giving and clinical decision
making in emergencies (18). Clinicians clearly felt less comfortable in
gaining consent for research than for clinical care, despite being
experienced in obtaining consent for emergency treatments. The
additional training given in taking consent for research in these
situations was welcomed by clinicians and may have increased study
participation. This is an area to be considered for successful
recruitment in studies using this approach to consent.
In an emergency intrapartum situation, time is critical, and it would be
unacceptable to delay emergency treatment in order to discuss consent
for research. Women in the COPE study, an ongoing randomised trial
comparing two first line PPH medications, do not consider verbal consent
to be approriate.19 For that situation, alternative
consent processes are needed. For example, in the COPE study, no consent
is taken but postnatal consent for use of data and follow up are
requested the following day. In the first 161 recruits to that study
only 4% were dissatisfied with this process of
consent.19 By way of contrast, in this study the PPH
Butterfly device was used as a second line therapy for those who
continued to bleed despite initial oxytocin treatment. This gave a brief
window of opportunity to discuss consent for the research. Despite being
only a very short time period, it is similar to the time taken for use
of standard therapeutic non-research interventions and the women in this
study felt that it was adequate for them to give a response. The
sensitivity and communication skills of the recruiting clinicians were
critical in this situation, as was their training to exclude any woman
who showed uncertainty about participating.