Methods
All women attending Liverpool Women’s Hospital for antenatal care
between January and December 2018 received information about the study
in the form of a participant information sheet. These were distributed
in antenatal clinics, community and hospital. Posters and leaflets
informing women about the study were also displayed in antenatal
clinics. Contact numbers for researchers and opportunities to discuss
the study with them were given to all women. Women at known high risk of
PPH, such as women with twin pregnancies, were approached for written
informed consent by a researcher in the antenatal period. If a woman
indicated that she did not want to be approached further, a sticker was
placed in her notes to alert clinicians to this. See figure 1 for the
recruitment process.
Obstetricians trained in use of the PPH Butterfly device were also
trained in gaining consent for research in an emergency situation. This
was provided as part of the overall intervention training process by a
researcher (WT). In the event that a woman experienced a PPH, the
attending clinical team would administer first aid to her, gaining
intravenous access, taking blood for grouping, and administering
oxytocin. During these initial procedures, the recruiting obstetrician
would also discuss the use of the device and gain verbal consent to use
the PPH Butterfly device should the bleeding continue. A script was
provided to the recruiting physicians and was signed by them after
recruitment (see Figure 2). The obstetricians were instructed to only
use the device if the woman was certain that she wanted to continue; if
she declined, appeared hesitant, uncertain, or confused then normal care
would continue without use of the device. The time taken to discuss
consent was typically 1-2 minutes. In those whose bleeding continued
despite the initial measures and who provided verbal consent, the device
was inserted, and uterine compression commenced alongside normal care.
The clinician was instructed to remove the device if at any point the
participant requested.
Following management of the situation and after sufficient recovery
time, the woman was approached by a trained research midwife to discuss
the study and obtain written consent. Women consenting to the study were
then asked to complete a questionnaire, which included a Likert scale
question on the acceptability of the consent process. Data were cleaned
and entered into SPSS; analysis provided descriptive statistics of the
responses to this question.
The qualitative aspect of the study explored the consent process through
the views of the women participants, their birth partners, midwives and
obstetricians. The qualitative approach was underpinned by Straussian
grounded theory methodology.6 Inclusion criteria were
that the participant was present at the birth and during the use of the
PPH Butterfly device. Women included in the main study were provided
with a participant information sheet by the midwife obtaining
retrospective consent. If women were agreeable, a different research
midwife (WT) contacted them by their preferred method, after a time of
at least 24 hours had elapsed. Interviews were completed at a time of
the woman’s choosing, usually at her home address, following informed
written consent. If a woman consented to interview, then a further
participant information sheet was provided to their birth partner and a
similar process followed. Obstetricians and midwives present when the
device was used were provided with participant information sheets. If
they consented, face-to-face interviews were conducted within a private
environment in the hospital setting. The sample size for all groups was
guided by data saturation;7 that is when no new themes
emerged from the data.
Interviews with all groups were semi-structured, with a topic guide
enabling focus to be maintained during the interview. Data collection
was completed in the three weeks following birth, in order to minimise
recall bias. Data were analysed using a framework analysis
approach.8 This approach is useful for facilitating
the constant comparative techniques required in grounded
theory.9 Data collection ceased when data saturation
was achieved as agreed by the two researchers completing analysis (WT,
CB). At this point data was becoming repetitive, with no new themes
emerging. Data were collected between January and November 2018.