Three themes were developed from the data: i) a woman centred recruitment process ii) optimising the recruitment discussion and iii) making a decision for two. Quotes are identified as originating either from women’s interviews (e.g., IP0162A, with A indicating accepting participation, D indicating declining), midwife interviews (e.g., Midwife 01) or recruitment discussions RD (e.g., RDP0162A indicates data from the recruitment discussion of a patient who accepted participation).
Woman-centred recruitment process
Womens’ and midwives’ accounts suggested a range of practices that would keep women and their interests at the centre of the recruitment process, most notably that study information should be freely available to all during pregnancy.
“If you don’t inform everybody, how could you possibly know which ones to inform? So, it’s better that the information is wider spread.” IP0162A
“The first time I heard about it was when I was having an antenatal appointment prior to even looking at my birth plan... I read a little bit about it then. I was thinking, oh that’s interesting, I wonder what’s that about.” IP0082A
Women also suggested community midwives should be the first point of contact with study information and research midwives agreed, aware the rapport women develop with community midwives was hard to replicate during an initial research approach in hospital. Further, whilst there was a clear belief that information should be given throughout pregnancy, many women suggested the third trimester was the optimum timing for receiving information.
“It’s worth people giving information leaflets out at [community] midwives’ appointments at like 36 weeks … IP0302A
“You’d build up trust and rapport with your [community] midwife…but when you meet a new member of staff who’s then giving you information about a study, it’s quite a big ask for them to trust you and agree to take part.” IMidwife01
It was felt that being signposted to information in advance of labour, through collaboration between community and research midwives, would avoid women receiving information for the first-time during birth admission, when there is little time to make a considered judgement on participation. This latter experience was reported by 15 women.
“It was sprung on me when I was about to be induced .... I think they should do it beforehand, maybe given time like when they go to their next scan or when they do their birth plan...not spring it when you’re about to go into labour.” IP0352A
“...having the opportunity to think about things, so perhaps have seen it in the hospital but be able to come back and watch [the patient video] again and have more processing time... I’d have been on a better footing then rather than having all the information straight away and making a decision at the time.” IP0162A
“...if they’ve had the information leaflet at least or they know a bit about the study before they come in... they’ve got that little seed in their head...it’s not such a big deal. They’re ready for it in a way.” IMidwife01
The third vignette involved 'Agnes' (Fig. 2) who was informed of the study prior to labour and initiated discussion with the research midwife in advanced labour. Most women and midwives favoured this scenario, some citing it as ideal.
“It sounds like she’d already decided she wanted to do it, she’d already accessed all the information and she actively asked for a midwife to come and speak to her about it. So, yeah, no problem.” IP0234A
Optimising the recruitment discussion
Finding the opportune time for midwives to make an approach and initiate a discussion was challenging given that many women were already anxious due to being admitted with a pregnancy complication or being in labour. Women, including those given information and approached about the study for the first-time during labour, did not overtly criticise the timing of their own approach. However, in apparent contradiction to this stance, they expressed concern about the timing of approach in ‘Libby’s' vignette (approached during labour, Fig. 2), with comments on vignettes possibly providing less guarded insights into women’s views:
“I think you'd have to question, is Libby in a sound state of mind...probably in a significant amount of pain, about to face one of the toughest things in her life that should not be the first time someone hears of the study, let alone is asked to consent for research purposes.” IP0264A
“I think I would have listened, tried to watch the video, tried to read or get someone to read it and then tell me or read it to me but then it would probably have been like, do you know what? Just shush please.” [laugh] Participant IP0308A
Women reported factors that hindered their ability to make an informed choice during labour including pain, pain relief, tiredness, vulnerability and anxiety, the clinical environment, and a lack of privacy. Pain relief was perceived to contribute to diminished capacity and some women relied on their partners to support their decision making.
“.. being approached when I was being induced worked for us... so he was able to kind of like, be there and watch [the patient information video] with me...I was drugged at the time [had been administered codeine].” IP0086A
The term ‘vulnerability’ was used by six women. It was used to describe being pregnant, labouring alone, a lack of control and feeling scared.
“Well, I think the whole pregnancy thing...it certainly made me feel quite vulnerable because it's not something I'd ever experienced before, and I had no control over...” IP0082A
“I was just so scared, in my head I was terrified that he'd be stillborn...So, I think if someone approached me and started giving me information [prior to hospital] ...I think that would probably scare the life out of me for labour even more than it already was scaring me.” IP0086A
This highlighted the importance of getting timing right, but also that women were vulnerable in different ways and at different times, meaning the 'right timing' will vary between women and reinforced the need for recruitment to be tailored to individual needs.
The midwives recognised that the hospital environment was not ideal for a research approach and were aware that women were unlikely to expect a first approach for research participation during their admission. The second vignette presented a scenario where the midwife initially offered clinical advice, then introduced the ASSIST II study (Fig. 2). Most women found this acceptable, but midwives raised concerns about this approach in this context, questioning whether it gave priority to research when clinical needs should be addressed first:
“I don’t personally think it matters that she was approached by the research midwife before the clinical one. I don’t see the issue with that.” IP0332A
“...the fact that she hadn’t seen a clinical midwife before the research midwife went in, I’d feel a little bit more uneasy about that because that’s not the reason she is here, to take part in a study, the reason she is here is to be induced.” IMidwife06
Regardless of the timing, however, allowing time to discuss the study with partners in privacy was valued.
“She left us with the [ASSIST II study video] so we could talk to each other and see, because obviously if she was sat there, you’d kind of feel a bit awkward if [partner] didn’t want to do it or something, but yeah, it was quite nice that she left you... you weren’t feeling pressured or anything.” IP0078A
“I’d just like to approach you both about the ASSIST II Study which we are currently running in this hospital, and I believe that [Partner name], you have had a chance to look at the information leaflet.” RCMidwife04
The midwives reported that providing engaging, accessible, and coherent information was, in their experience, important to women. Some modes of information provision, however, were rated more highly than others. The PIL was intended to raise awareness of the study during pregnancy but was criticised by some women and midwives for its appearance, content, and length. Midwives noted that decisions to participate were rarely based on its content, and this was supported by some women, who described it as wordy and off-putting:
“... it was quite wordy almost put you off wanting to read it because you think, oh like if they were shorter paragraphs or whatever you think, oh I can read this in two minutes, done.” IP0215A
In contrast, women valued the information video’s visual demonstration of how the Odon would be used in practice. Midwives valued the video for the clarity it offered women.
“I remember being quite impressed that it felt very much like everything had been thought through so that video gave you all the information you needed.” IP0082A
“So, it was the visual explanation of the bag going over the head and how the baby was then moved down the birth canal and out. I remember seeing that bit...” IP0215A
“Before we launched, I thought it was an additional tool to our chat but now I think it’s an instrumental part...I think probably it’s the seeing the device in operation rather than people talking around it.” IMidwife02
The recruitment discussion was seen as pivotal in promoting understanding. Women commented positively on the content and manner of information provision, regardless of their decision about participation, with sixteen (thirteen accepters and three decliners) recalling the discussion as being essential for decision-making.
“I just bombarded her with questions…So, I’d say her knowledge was quite brilliant, reassuring...it gave me confidence.” IP0332A
“…it is a special time for you, your husband, and the midwife, that relationship, so I think it’s important not to impose too much on that, and the researcher I spoke to didn’t. I think she was very courteous in that way, but yeah, I think if you took up too much of someone’s time on the day, it perhaps takes away a little bit of the special experience and I think that just adds more to the argument about giving the information earlier.” IP0181D
It is worth noting the final point made by IP0181D, which highlights the risk of a recruitment approach imposing on a special time and supports the idea that an approach prior to labour is preferable.
Combined, women asked 40 different questions during recruitment consultations, (presented in Table 3). Most questions focused on the Odon and the baby’s ability to breathe during birth, whilst the fewest focused on research follow up. Six women asked no questions. One research midwife noted that because of the comprehensive nature of the information video, conversations were often brief.
Table 3
All questions asked in the recruitment consultations
Themes / Questions
|
Participant
|
KNOWLEDGE OF THE BD ODON DEVICE
|
|
What is the BD Odon? Never heard of the BD Odon
|
80D,81A
|
Is the BD Odon better than other tools?
|
77D, 228A,235A,255A, 200A,201A
|
What does the BD Odon look like
|
201A
|
What is the BD Odon made from?
|
215A
|
Is the BD Odon recyclable?
|
215A
|
THE BD ODON DEVICE IN PRACTICE
|
|
How many BD Odon attempts had been made?
|
234A
|
What fetal positions are suitable to use the Odon?
|
234A,255A
|
What does a success rate mean?
|
284A
|
Were all the BD Odon attempts successful/success rate?
|
77D,86A,235A
|
What are the pros and cons of the BD Odon?
|
215A,
|
Is it more complex procedure?
|
235A
|
Why does the BD Odon fail?
|
200A,215A,228A
|
What if the device fails?
|
78A,215A,235A
|
Is there less of an infection rate with the BD Odon?
|
284A
|
When is the BD Odon not used?
|
235A
|
Negative side effects/risks of the BD Odon
|
215A,235A,255A,302A
|
THE BD ODON & SAFETY
|
|
Does the BD Odon have a CE mark?
|
86A
|
Has there been any harm to the baby or mum?
|
77D
|
If other procedures are safe, why has the BD Odon been introduced?
|
215A
|
Is the ventouse the size of the baby’s head?
|
77D
|
Will my baby suffocate from the cuff/plastic?
|
77D,86A,215A,228A,255A
|
Do BD Odon births have an effect on neonatal hearing?
|
215A
|
Are forceps too hard for the baby’s head?
|
77D
|
Are there any known neonatal injuries from the BD Odon device?
|
215A,
|
Do babies have marks/scratches from the BD Odon?
|
235A
|
Does the BD Odon device contribute to more perineal tearing?
|
78A,80D,302A
|
The benefit of an episiotomy over the risk of tearing
|
80D
|
Do you have to have an episiotomy with a BD Odon birth?
|
234A
|
THE BD ODON PROCEEDURE/BIRTH
|
|
How long will the procedure take?
|
77D
|
Do we wait for a doctor to do the BD Odon birth?
|
255A
|
What if my baby is distressed and there is a delay to using another instrument after the BD Odon?
|
235A,255A,
|
Can the BD Odon harm the baby?
|
86A,201A,215A,
|
Is the BD Odon quicker or take longer than using other instruments?
|
86A
|
Is the BD Odon an elective procedure?
|
200A
|
Are the BD Odon operators specially trained or experienced?
|
82A
|
Does an Odon birth prevent a water birth?
|
302A
|
FURTHER INFORMATION
|
|
Can I search the video on YouTube?
|
77D
|
STUDY FOLLOW UP
|
235A,255A
|
What is asked of women in the follow up?
|
235A
|
Do I come to hospital for the follow up or the qualitative interview?
|
302A
|
NO QUESTIONS
|
81A,162A,179D,181D,249D,308A
|
“Most women turn round and they’re like ‘oh, I was going to ask you that question actually about the baby breathing, but it was all covered in the video.” IMidwife04
‘Good’ conversations were defined by midwives as exchanges where the midwives’ believed women were optimally informed, either because of evidence of previous access to study information or because women were able to ask probing questions.
"Good conversations, definitely the majority of women have had the information before.” IMidwife06
“The people that I’ve approached, had a conversation with and walked away feeling like yeah that was really, really good were the ones where they asked the most questions...you feel that they’ve got all the information and they’ve made the right decision”. IMidwife02
“...if they’ve had the information leaflet at least or they know a bit about the study before they come in... they’ve got that little seed in their head...it’s not such a big deal. They’re ready for it in a way.” IMidwife01
The physical state of the women, access to prior information, the timing and location of the discussion, and the length of time given to make a decision about participation were most influential in how positively women perceived the discussion, irrespective of whether they accepted or declined participation. At interview, two weeks postpartum, there was no consistency to the elements of participation that women could recall, although most acknowledged their lack of knowledge about study detail. This inability to recall was reported by women regardless of whether they gave consent on Central Delivery Suite or in pain. Those who had only partial understanding at the time of their decision appeared to accept this as sufficient and place their trust in the study team:
“To be honest with you...sort of understood it a little bit, what would happen and why I would need it.” IP0308A.
Other women demonstrated a clear understanding of what they consented to:
“I consented to, if the right person was available at the time and I needed an assisted delivery that I would have one. So, I consented to going along with it to the point of delivery and then sort of re-evaluating whether I definitely still wanted at that point.” IP0235A
Most women were given a short time by the research midwives in which to consider participation, but some indicated having ample time to consider, as illustrated by the following excerpt from a recruitment discussion:
“So, I'm around for another few hours now and then I'm here again tomorrow. If you decide to sign up prior to that ask the [clinical] midwife to give me a shout and I'll come back down.” RCMidwife02
This woman was followed up the next day. After all her queries had been answered, she felt comfortable with her decision to participate.
RCMidwife02: “Would you like some time to think about it you wanted to take part in the study?”
RCP0235A: “No. I think we’re happy to participate in it.”
Making a decision for two
One issue above all others influenced decision making: women were making a decision for two. Any other motivation for participation came with the caveat that there must be no risk to their baby.
“...as long as it definitely doesn’t hurt little one that you know, I’m happy to help out with the research. That was my only main priority.” IP0308A
Midwives suggested that some women were taking some control over their baby’s birth by participating. One midwife recalled a woman, traumatised by her first child’s birth, initially rejecting participation before thinking again after her husband made the point that participating gave her another option during labour.
“...she said, ‘oh no, I’m really anxious, this is just too much now’...then she came sobbing back into the office....’my husband just made the really good point of it gives me another option before having to have another caesarean section’.” IMidwife05
Women also compared the Odon to other methods used for AVB. After engaging with the study information most women believed the Odon to be a better option, with the absence of hard surfaces on the device leading women to believe the Odon was gentler for both themselves and their baby – which suggests an incomplete understanding of equipoise. Twenty women perceived the Odon to be a preferable alternative to forceps and participated with the aim of avoiding a forceps assisted birth.
“...I think anyone who's either had it or nearly had to use forceps, it's always been like, 'oh no, they had to use forceps.” IP0264A
“It just looked a bit better and a little bit safer, for me, ‘because it went over the head...I don’t know, just looked a bit safer for me than the forceps.” IP0081A
Women declining participation in ASSIST II gave a range of reasons (including fear of something going wrong, concern for the baby’s wellbeing, resistance from family members). When comparing women who declined with those women who accepted participation, none of the decliners had study information prior to the discussion. Most women who declined participation reported doing so because of late information, explaining they would have considered participation with prior information. Decliners also included proportionally more women with English as a second language who did not have translated information available to them (three of five decliners compared to two in twenty of those accepting).