Twenty two women opted for a face to face interview and 20 of these were interviewed. Their accounts suggested that they were between 22 and 33 weeks pregnant at the time they were recruited into the ORACLE trial. Women were mostly white (n
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19); 18 were married; 11 were in employment; and none had been educated to university level. Most (n
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13) had at least one child before the ORACLE trial and seven had had a previous premature delivery. Accounts from 10 women suggested that they had ruptured membranes at the time of the trial; the others were in pre‐term labour. Although participants had been drawn from a single UK region, they had been recruited to the trial at multiple trial centres.
Being asked to participate
Although nine participants mentioned being provided with the trial information sheet at the time of recruitment, the sheet appeared not to play a prominent role in the decision to participate in the trial. For most women the decision to participate was primarily based on their exchanges with the healthcare professionals who made the recruitment approach, and appeared to involve a response to socioemotional aspects of those exchanges rather than their informational content.
“Yeah, but she was lovely, she took her time with me and said, you know, anything that I wanted to do, she came back in an hour to see, you know, if I'd made me mind up or I could, you know, let her know whenever. But I'd made me mind up straight away and she was, you know, took her time with me over everything.” (Participant 1)
Those mentioning the amount of information provided about the trial (n
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7) were satisfied. Comments on the quality of the information given were generally favourable, although women's accounts suggested that their ability to absorb information was compromised by the stressful nature of the situation.
“… they were very, very sympathetic and receptive to anything and spent time explaining. But there's only, to be fair, when everything else was going on around you – there was only so much I took in and, I don't know, I can't say that's a complaint because that's just what's happened, I don't know how much I understood at the time because I was more worried about everything else.” (Participant 8)
Information women recalled being given included information on the placebo, the potential for antibiotics to prevent premature delivery, the safety of the antibiotics, and the potential for the trial to assess the usefulness of antibiotics in threatened premature delivery.
Knowledge of trial practices
Accounts from more than half the participants suggested that they understood that the aim of the trial was to examine the usefulness of antibiotics in preventing pre‐term labour, but there was little mention of other trial outcomes including infant mortality and morbidity. Trial practices including use of placebos, randomisation, and blinding appeared to be poorly understood. Although all but one account mentioned the use of a placebo or “dummy” tablet and recognised that trial participants (and usually the healthcare professional) would be blinded to the treatment arm, the reasons for these practices remained obscure for women.
“… you don't know, at all. That's the information that you get, you will not know what drug, whether you are on the drug or not, because all the tablets are the same, even the staffing people don't know. So nobody knows except the people that are hundreds of miles away, do you know what I mean? You think, ‘Well thanks, just hold my life in the balance'.” (laughs) (Participant 4)
Some indication of why a placebo might be useful was demonstrated in just five accounts.
“That's right, yes, because you've got to have a comparison haven't you? Otherwise there's no point doing the trial, so yeah.” (Participant 20)
Two women believed that their part in the research was less valuable if they took the placebo and one thought that if she was taking the placebo she was not in the trial. Three expressly stated that a placebo was unnecessary. Many felt that taking the placebo would involve additional risks, mostly because it would involve not taking the active treatment.
“… knowing that perhaps I could be taking something that would be of no use whatsoever was a little bit sort of worrying that I was trying to do, trying to stop going into premature labour but the, you know, obviously taking these tablets would make no difference whatsoever.” (Participant 3)
Blinding was a particular concern for the participants, with most wishing to be unblinded. Women offered different explanations as to why blinding might be necessary, with only three accounts suggesting it was necessary to ensure any effect was a real effect. Four women believed it was necessary to prevent the trial being blamed for an adverse outcome, including distress to women who did have a pre‐term delivery.
“There could be a lot of blame and then a lot of anger and it's a horrendous thought anyway to go thinking that you're going to lose your baby, so to, if you'd actually lost one and you're on the placebo, oh wow, the bitterness you could actually feel, in fact I've gone cold thinking about it cos it just, it's just, you've got to blame somebody haven't you?” (Participant 12)
Motivations for taking part
Two motivations for taking part were prominent in women's accounts. The first, given by half the participants, was to help other women and their babies in a similar position.
“I was, I mean, I was all for it because anything that helps future generations, if they'd have found out that antibiotics did help then it's helping thousands of women after isn't it?” (Participant 7)
These women believed that research was desirable and indicated a strong sense of solidarity with other women. Willingness to help, however, was conditional on there being no risk.
“I mean no, I mean what they would be doing for me was either beneficial or not working at all so it wouldn't have caused any adverse effects for me, but all I could think was it's not gonna harm me or the baby. If it does help anybody else in the future, these trials do result in something being learned, I'm glad to help.” (Participant 15)
The second and, for women, much more important motivation for trial participation was the possibility of an improved outcome for their pregnancy. Fear of giving birth prematurely was a prominent feature of many accounts. All but two of the women believed that, by agreeing to take part in the trial, labour might be delayed, making a successful outcome to the pregnancy more likely. Faced with the possibility of giving birth prematurely and seeing the ORACLE trial as a way in which this might be prevented, the decision to take part appeared straightforward.
“At 32 weeks with [baby's name] and I was just kind of laying on the bed and the doctors came in and asked me if I wanted to take part in the trial and we just agreed straight away. Yeah, because we both felt that if, well we just felt it was too early for him to be born and so if there was a chance to stop it we wanted to take it.” (Participant 13)
Patients were very clear that they did not feel pressurised by staff to take part in the ORACLE trial. However, the situation they found themselves in exerted considerable pressure.
“I mean, like me at the time, if they'd have told me that if they chopped me leg off it would have stopped the baby coming, do you know what I mean? It were just so scary. The doctors kept saying, you know: ‘If it comes now [..] it could have brain damage and this' and everything were just so scary, and then they said: ‘We're doing this trial to see, you know, this is ORACLE and this is what it's all about.' And I were just like: ‘Yeah, yeah, just …' you know, you just sort of say: ‘Yeah, do it'.” (Participant 6)
Risks associated with participation
Although at the time of interview women had received the leaflet summarising the results of the trial, including the finding that one arm of the trial was associated with an increased risk of necrotising enterocolitis and that antibiotics are effective only for women with pre‐term rupture of the membranes, women's accounts showed little recognition of these findings. Most women (n
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15) believed at the time of recruitment—and continued to believe—that there was no risk associated with taking part in the trial or that the main risk in the trial was being allocated to the “wrong” arm of the trial and receiving the placebo rather than the antibiotics. Many women reported being told by healthcare professionals that there was no risk associated with the trial. The perception that there were no risks intensified the feeling that there was “no choice” about whether to participate.
“When the nurse said: ‘We've got this trial. There's no harm to the baby that it can cause but it can, if you are in premature labour it can halt things or, you know, carry you further forward.' So for me there was just no choice, you know, that's why I went on. I thought, well if there's no detrimental effect with them then obviously it may make a difference, it may not but the chances, yeah, so that's why.” (Participant 3)
Some women drew on “common sense” knowledge about the benign nature of antibiotics to conclude that that the interventions were harmless. Others (n
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7) relied on the credentials of the hospital, the health professionals, or the research process, trusting that they would not expose women or their babies to anything hazardous.
“Still feel the same. End of day it's only antibiotics which a doctor would give you if you've got a cold, a cough, or whatever so I just felt as if it couldn't do us any harm. It was either gonna work or it wasn't, you know, at end o' day it weren't causing anybody … it weren't causing either me or my baby any harm in any way.” (Participant 16)
“Yeah, cos I knew they wouldn't, I knew the hospital wouldn't put me at risk, and I did ask a lot of questions at the time.” (Participant 7)
Those women who remained concerned about taking drugs during pregnancy (n
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4) balanced the risk of taking the tablets against what they saw as the greater risk associated with premature birth.
“The fear of losing the baby took over which made me decide to try it anyway and then the first couple of tablets I took I was sitting there scared thinking of what was gonna happen to me, you know. But I carried on taking them and I just hoped that they'd help, you know, but … yeah, I was more frightened of losing the baby. The fear of that took over my fear of tablets.” (Participant 10)