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Table 4 Representative quotations

From: A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT

Theme Quotationsa
Motivations for participation PW02, participating in APOSTEL VI: I like to participate when it is positive for me, when participation makes me feel like I do something good, but that it is also positive for myself and that nothing can go wrong.
PW12, not participating in APOSTEL VI: It depends whether participation is beneficial for yourself or whether it is purely for science. In this case, I considered it a valuable bonus that the pessary could potentially help to prolong my pregnancy.
PW13, not participating in APOSTEL VI: [Healthcare professionals] did not want to perform internal examinations to prevent stimulation of the uterus. So I figured, if you insert a pessary, then you can also stimulate it. I was afraid of that.
HCP02, research midwife: It is first and foremost herself and the baby. Saving the world comes secondary.
HCP04, gynaecologist-in-training: Why would you do an intervention, why would we do something that has not been proven? I also wonder what the working mechanism of the pessary is, nobody can tell me, not even the big advocates.
Counselling HCP13, gynaecologist-in-training: It is an easy study to recruit people for, because it involves people who really want something, and you have something to offer.
HCP05, gynaecologist: You can only achieve fair inclusion when you ask each and every pregnant woman who potentially meets the inclusion criteria.
HCP10, research midwife: If they are eligible, we ask them. In the following conversation I may determine that they are not suitable, for example because they do not understand it [the study]. We also have drug addicts here, where you decide that it is not a good idea because that lady doesn’t belong to the group of women the study is interested in.
HCP08, midwife: If there is a study where you think ‘I’m not sure what I’m doing here’, it is definitely a reason to counsel in the other direction. You try to counsel objectively, but we all know it is directive.
HCP13, gynaecologist-in-training: Sometimes you know that it is not the right candidate. That it will be a mess. And then you counsel slightly more negatively.
Gatekeeping PW07, participating in APOSTEL VI: I had so many doubts, I really didn’t know. You are as mentally unstable as it can be when you lay there hospitalised so I couldn’t make a good decision. Yes, many people where involved [in the decision-process].
PW11, participating in APOSTEL VI: I notice that you think different about things when you are pregnant, it may be hormonal or not, but you are surely different in terms of decisiveness in comparison to when you’re not pregnant.
PW03, not participating in APOSTEL VI: Sometimes I realise that I am less resolute in my decisions because I am pregnant. […] More doubtful and no completely following, like “oh no, what was it [that I missed]?”. For that reason I turn to other people.
PW08, not participating in APOSTEL VI: Everyone makes you aware of the fact that, as a pregnant woman, you are part of a weaker group. That you should be handled with great care.
HCP01, research midwife: A dad finds it burdensome: ‘there they are yet again with a study; she is already tired, she is sleeping, no, I don’t think that she will participate’.
REC05, gynaecologist: I notice that clinicians are protective towards patients, for example in that they do not mention ongoing scientific research.
HCP08, midwife: Sometimes we ourselves decide that someone is not suitable. Because of the language, or when you wonder whether someone will understand it, or because someone is already participating in two other studies.
HCP03, gynaecologist-in-training: The child cannot decide if he wants to participate in a potentially dangerous study. […and a pregnant woman] cannot estimate or oversee the risks for a child that may has to become 80 years old.
HCP14, gynaecologist: Assuming that women may function differently during their pregnancy, also psychologically, you don’t know if that does not influence their decision-making surrounding research participation.
HCP13, gynaecologist-in-training: I think they [pregnant women] are behaviourally more vulnerable. I think they have some sort of black, blind spot: everything for the child. […] They are not sufficiently competent.
Interest in (routine) inclusion HCP05, gynaecologist: Routine inclusion may be a little odd, but if you have the premise that there is a theoretical or practical basis to assume that a given therapy improves or can improve the pregnancy outcome, and you meet the strict guidelines of among others the REC and the WMO [Dutch regulation on the protection of human subjects], and you carefully register the outcome of the pregnancy and the side effects, I think that that would actually be very good.
HCP03, gynaecologist-in-training: The question is whether there are no good alternatives. Is research really necessary?
REG01, MEB member: Observational research has a different approach, where we do not intentionally expose pregnant women, but where women are already exposed and we try to collect data in the best way.
REC04, clinician: You should not expose pregnant women to medications of which the effects on the baby are unknown, if you have an alternative. It’s different if it is pregnancy-specific. In that case you don’t have an alternative, and then I have fewer objections.
PW02, participating in APOSTEL VI: I would not participate in a study where I have to take medications or where things are injected into me. I don’t want to be a guinea pig for that.
PW12, not participating in APOSTEL VI: If possible, I would not accept any research with risks. Why would you take risk if you don’t have to, if there is no direct benefit? I wouldn’t take that risk for science.
  1. a Quotations are sometimes slightly modified in order to enhance readability