Background
Methods
Design
Selection of trials and interviewees
Trial acronyma | Research question | Treatment arms | Eligible women |
---|---|---|---|
Allo [9] | Does antenatal allopurinol administration reduce hypoxic-ischaemic encephalopathy in neonates exposed to intra-uterine asphyxia? | Allopurinol or placebo, antenatal administered to the mother | Women at term in whom the fetus is suspected of intra-uterine asphyxia |
Apostel I [10] | Is testing for fibronectin a cost-effective strategy that prevents unnecessary treatment in women with threatened preterm labour? | Tocolytics (nifedipine) or placebo | Patients with symptoms of preterm labour, and a negative fibronectin test and a cervical length between 10–30 mm |
Apostel II [11] | Does sustained tocolysis in women with threatened preterm labour reduce neonatal morbidity? | Nifedipine or placebo for 12 days | Women between 24 to 31+6 weeks pregnant who have been treated with tocolysis and steroids for preterm birth for 48 h |
CHIPS [12] | Is there a difference on pregnancy loss or NICU admission between less tight and tight control of blood pressure in women with non-severe non-proteinuric pre-existting hypertension or gestational hypertension remote from term? | ‘less tight’ dBP control or ‘tight’ dBP control | Women with non-severe non-proteinuric pre-existing hypertension or gestational hypertension remote from term |
Hypitat II [15] | What is the effectiveness and efficiency of induction of labour in women with pregnancy induced hypertension or mild preeclampsia with a gestational age of 34–37 weeks of pregnancy, as compared to expectant management under regular monitoring? | Induction of labor or expectant management under regular monitoring | Women with pregnancy induced hypertension or mild preeclampsia with a gestational age of 34–37 weeks of gestation |
Ppromexil [14] | What is the effectiveness and cost-effectiveness of induction of labor after PPROM between 34 and 37 weeks gestation compared to expectant monitoring. | Induction of labor or expectant monitoring | Pregnant women with preterm premature rupture of membranes between 34 + 0/7 weeks to 37 weeks of gestation |
ProTWIN [16] | Is prophylactic use of a cervical pessary effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy? | Pessary or no treatment | All women presenting with a multiple pregnancy between 12–20 weeks of gestation |
WOMB [13] | What is the effect of RBC transfusion on health related quality of life? | RBC transfusion or no intervention | Women with PPH or a decrease in Hb, 12 to 24 h after delivery or caesarean section. |
The interview
Analysis
Results
Interviewees
Code | Ethnicity | Level of education | Age | Study | Paritya |
---|---|---|---|---|---|
Participants | |||||
J | Dutch | Intermediate/low | 30-34 | Allo | Nulliparous |
L | Dutch | Higher education | 35-39 | Allo | Parous |
M | Dutch | Higher education | 30-34 | Allo | Parous |
N | Dutch | Higher education | 25-29 | Apostel I | Parous |
P | Dutch | Higher education | 25-29 | Ppromexil | Nulliparous |
Q | Dutch | Intermediate/low | 25-29 | Ppromexil | Nulliparous |
T | Dutch | Higher education | 30-34 | Hypitat II | Parous |
U | Dutch | Higher education | 35-39 | ProTWIN | Nulliparous |
V | Non-Dutch | Higher education | 35-39 | Hypitat II | Parous |
W | Dutch | Higher education | 35-39 | Apostel II | Parous |
Y | Non-Dutch | Higher education | 35-39 | CHIPS | Parous |
Z | Non-Dutch | Higher education | 25-29 | WOMB | Parous |
Non-participants | |||||
A | Dutch | Higher education | 35-39 | WOMB | Parous |
B | Dutch | Unknown | 25-29 | ProTWIN | Nulliparous |
C | Dutch | Higher education | 30-34 | ProTWIN | Parous |
D | Non-Dutch | Higher education | 30-34 | ProTWIN | Parous |
E | Non-Dutch | Higher education | 35-39 | Hypitat II | Parous |
G | Dutch | Higher education | 25-29 | Apostel II | Nulliparous |
I | Dutch | Higher education | 20-24 | ProTWIN | Nulliparous |
K | Dutch | Intermediate/low | 20-24 | Ppromexil | Parous |
O | Dutch | Intermediate/low | 20-24 | Hypitat II | Nulliparous |
Main motive for trial participation or non-participation
Code | Citation |
---|---|
J | “I don’t think research is ever actually bad, and this is not a study where they do real experiments, so it’s always good to learn from it for someone else.” |
L | “Actually, in our first pregnancy our daughter was in foetal distress and so we had to have a caesarean section. This might have been an option then, too, as it has something to do with foetal distress, then administering this. And my husband actually asked more questions: does it have drawbacks for the child? No? Then we’ll join, because the study is necessary. |
There’s also my medical background. I’ve worked on maternity wards, too. When you work in medicine, you’re open to innovation and new techniques.” | |
T | “Two things, actually. In my first pregnancy I had pre-eclampsia, so I was very well aware what the consequences might be for me, and then also for the child… Personally, I support the aims of the study, to let you have your baby from 34 weeks onwards, because the risks do not outweigh for mother and child, so to speak. Second, I’ve been coming to a teaching hospital for years, for other treatments as well, and I believe very much in the academic side. I believe in development and trying new things. And, well, research is part of that because if you never do any studies, you can never do anything new.” |
U | “Well, originally I was invited to take part in a study about the pessary, a study of twins. I thought: seems good to me, I have a twin sister myself and I used ICSI to conceive, so there were also people who took part in this kind of study for me. That’s how I’m pregnant now.” |
Z | “Well, first, it did really apply to me and there was the choice between taking blood or iron. Otherwise it would have been iron, whatever. So I thought, let’s see what happens with this. And I was in the blood group. Looking back, I’m very happy with it. And, as I just said, I often do studies myself. So then you know better how important it is, that you need to recruit people, so erh, actually that’s the only reason.” |
M | ”The most decisive factor, of course, is that the consequences of oxygen deprivation are pretty severe. If you could reduce that in some way, by taking a particular drug, then I’d choose it. Yes, yes, good. And because the drug was already being used for other things – OK, so it hadn’t yet been fully tested for oxygen deprivation – then it shouldn’t have any bad effects. You assume that it can only be beneficial. And so then I think, like, that’s something I want to take part in.” |
P | “OK, well, that was mainly due to the fact that there was a chance that my labour would be induced, otherwise I’d have to wait until 37 weeks come what may… The contribution to research as well, of course, I thought that was a good cause, but it wasn’t the most important. I thought: I’m going for immediate induction. I couldn’t imagine having to stay in hospital for five days, not allowed to do anything, so I thought, like, let it come now.” |
Q | “First of all, I don’t see myself lying here for another five weeks. And pretty soon after that the realisation that you’re already open down there, with a risk of infection for yourself and for the baby. And yes, in Enschede the doctors also said it was viable enough, so that was for us a reason to take part.” |
V | “That once the baby was out my high blood pressure would be gone. That’s what I thought, that was about it. But on the other hand, I was a bit scared. Will I have him earlier – that was at 36 weeks – so it was a bit of a dilemma deciding what would be best. Then she explained to me: the earlier the baby’s out, the better it should be for mother and child. So that was actually the reason why I said I’d do it.” |
W | “That was because I hoped it would be better for the baby, although I still had an uneasy feeling about it. That was because nobody could say what the potential adverse effects were. Yes, I kept on feeling uneasy about it.” |
“And I had something like, in my case it can only be positive, because I mean, the test would indicate whether the chance was very high that you would deliver very soon, or that it could take a while. So, I really felt like, I felt that I ran little risk, because if the test would show that you would fall into the test group, than you would get either a placebo or tocolytics.” | |
N | “And I thought something like, in my case it can only be positive because, I mean, the test would indicate whether the chance was very high that you would deliver very soon, or that it could take a while. So I really felt like I wasn’t running much risk, because if the test showed that you fell into the test group, then you would get either a placebo or tocolytics.” |
Y | “Then you know how and what.” |
C | “Well, there were several reasons actually. When your colleague started talking about it, when I had an appointment about it, I thought: ‘Oh my God, no, not a pessary! Because I had a friend who was admitted to hospital because a pessary [not in pregnancy] had caused a lot of bleeding. So that’s what I told her [the colleague]: that that had been a life threatening situation. So I had a feeling of, like, if I think now about pregnancy and a pessary, it doesn’t make me very happy.” |
D | “For me it was pretty clear, actually. Once I was here I thought, like, just let Mother Nature do her work. I’m pretty religious [Muslim], so perhaps there’s a reason why those children are born early. I believe in God, you know. I think, like, fate decides. If those children want to be born earlier, then so be it. If not, then not. That was my thinking. I was scared, too. What if I take part and something happens to me, a bit of blood loss – or a lot – or something happens to the babies.” |
E | “She [baby] was four weeks early and that blood pressure kept on rising. They just couldn’t get it down. I’d already been lying there for a month and I’d had enough. You want something to happen. Then they asked me: do you want to take part in this study? Because there’d come a point when the doctors were saying, we don’t know any more, either. So I thought, well, if they don’t know, who does? I had to make my own choice. … And then I thought, actually I can better prolong it for a while, to see how long it takes. Because if I had decided to take part, you don’t know whether you’ll be induced or not. That’s not certain, either. So then the disappointment can be huge. That was when I decided not to do it, to see how long we could prolong it.” |
G | “I had a very tough pregnancy, with a lot of bleeding, and in fact the whole nine months were entirely uncertain… I was given those lung development injections and I tocolytics, after which I couldn’t feel my baby at all… When they asked if I wanted stay on the tocolytics, I linked them a bit with that so I thought, like, no – because I wanted to feel my baby again as soon as possible, to regain a bit of the certainty that everything was alright. So for me, that was the most important reason.” |
I | “At first I was really inclined to participate, because a lot of people close to me said, just say it works. Your babies will stay inside longer. But personally, I had the feeling that everything was going very well, that it all, yes… And I do react quite strongly to things, to jewellery or a piercing or something. So I think, if something’s going to be stuck inside my body, it might react really badly. If nothing’s wrong and I do that… I found that a bit scary. And then there’s the fact that you couldn’t choose which group you were in. That’s logical with a study, but that’s why I didn’t do it in the end.” |
K | “Well, it’s not without a reason that they tell you that you’re officially allowed to deliver from 37 weeks on, so yes, I thought it was a risk being induced at 34 weeks. Because the doctors don’t just say: from 37 weeks the doctors will induce you automatically and they’re doing a study and I didn’t want to be a guinea pig. If something then goes wrong …” |
A | “I would happily have taken part if I could have opted for iron tablets, but that choice wasn’t available. You have to participate blind, and then I don’t know who decides. I don’t know how that works, but someone else decides for you which of the two you are going to do. What’s also complicated: I didn’t want a blood transfusion. I was lying there on a drip and I had a catheter, and then I thought that with iron tablets I could go home and otherwise I would have to stay even longer.” |
B | “I’m at the AMC. That’s a teaching hospital and they do all kinds of research there. I would have to come in more often – it was all about a pessary against premature birth – and I would have to come in more often to measure it up and for ultrasound. I did seriously consider it, but those extra visits… If was in pain, for example, or it wasn’t convenient. And I’d just heard I was pregnant with twins sharing an amniotic sac, which is a very rare situation – you have a lot information coming at you.” |
O | [Unplanned pregnancy] “Yes, and everything suddenly went so fast. Then I really thought, like, well, I don’t have to be induced tomorrow. That… the chance was 50%, and I didn’t need that. No, I feel it’s all gone too fast. Because you’re… No… After three weeks attending the hospital, I was admitted. I’d never been in hospital before and… Yes, yes, I was homesick. Yes. But, I didn’t think, like, whip him out tomorrow. Really, that just wasn’t what I wanted. That was simply too fast for me. I couldn’t take it all in.” |
Themes identified as related to the decision on trial participation
Theme | Sub codes |
---|---|
External influence | ▪ Concern from social environment |
▪ Trust in the health professional | |
▪ Feeling of disappointing the health professional | |
Research and healthcare | ▪ Familiarity with scientific research |
▪ Willingness to contribute to research | |
▪ Feeling of participating in an experiment | |
Perception own situation | ▪ Perception own situation and medical history |
▪ Feeling very eligible or very ineligible for scientific research | |
Study design | ▪ Randomization |
▪ Blinding | |
▪ Placebo | |
▪ Additional efforts | |
▪ Insurance medical research | |
Intervention | ▪ Intervention |
▪ Natural course | |
Information and counseling | ▪ Written information |
▪ Counseling: information and timing, atmosphere | |
▪ Time for consideration on participation | |
Uncertainty | ▪ Fear |
▪ Stress | |
▪ Doubt | |
▪ Physician does not know what is best |
A. External influence
“I did discuss it with my husband. Myself, I already thought, like, I’m fine with it. My attitude did depend on what my husband would say, too, but he said something like: that’s good. So we agreed. Interviewer: “And if he [your partner] hadn’t agreed?” Participant: “Then I wouldn’t have done it.” [Participant Allo trial]
B. (Contribution to) research and healthcare
“And I also looked at it like this: these are studies for the future, and after all I have a daughter and you never know. In that case I’m the kind of person to take part in things for other people, so that it’s better in the future than it is now, for example. What other people have done in the past, I’m making use of now.” [Participant Hypitat II trial]
“Maybe they should be a bit more up-front about saying, if people are pregnant anyway, that there are studies that people can take part it. Maybe that it’s passed on to people in some way or another as soon as they fall pregnant, so that you know about it. I didn’t think about it. I’ve never experienced this before. I think that would cause less stress. Say you get leaflets in advance, “scientific research for pregnant women”, and you’ve read them. Then you know already that it might come up. You can already think about it.” [Participant Ppromexil study]
C. Perception own situation
“There are people who do that [participate in trials], and that’s all very wonderful and good, but I’m not that kind of person. You know, no playing about my body. Maybe if it was just one [baby], but now it’s already scary and if there’s going to be all that fiddling with your body, then give me the natural way.” [Non-participant ProTwin]
D. Study design
“Because if I had decided to take part, then are you going to be induced or not? That’s also a doubt. So then the disappointment is huge. No, the uncertainty; [if you decide for yourself,] you go in and you know where you’re going.” [Non-participant HYPITAT II]
E. Intervention
“Well, yes, if they stay inside longer in that case, than that’s an advantage for me, too. Actually, that was my only reason for taking part. But I did need to be convinced that there wouldn’t be any drawbacks if they didn’t stay inside so long because of it.” [Participant ProTwin trial]
“To me it was already pretty clear, actually. Once I was here I thought, like, just let Mother Nature do her work. I’m not going to mess around with with something if nature has decided that’s the way it is. I let it be, you know.” [Non-participant ProTwin trial]
F. Information and counseling
“But maybe with hindsight I think it matters a lot: the person who comes to tell you [about the study]. If someone like Ms J [the research midwife] had come to my bed at the beginning and taken her time over it, then maybe I would’ve thought differently than when you have a doctor perched on the window-sill, only just not looking at her watch, saying I’m just popping in for five minutes and then I’m gone and you have to make a decision. Because you have to join the study at two o’clock this afternoon, otherwise it’s too late. Yes, that feels different and the results are different. Perhaps even when it comes to taking part in the research.” [Participant Apostel II]
“These are the same tocolytics you normally get, they’re no different. It’s not a new drug, but I only realised that later. It wasn’t made clear at the time I had to decide. It looked like it was a new drug, or a new way of seeing whether it can be kept inside longer if your waters break early, and what harm that could do to the child or the mother. In other words, in the future, when people come in with waters that have broken early, can we give them these pills with confidence? That was my feeling about the study, actually, and when I had to say yes I didn’t know that it was the same drug and what harmful effects it might have. If that was all explained very clearly then, including the harmful effects it might have – that’s the research, of course – then I’d join more easily. If they can say that the only harmful effect is that he’ll a bit smaller or a bit bigger, or a bit more to the left or a bit more to the right… But if you don’t know that, then it’s pretty difficult. It’s a whole ethical issue.” [Participant Apostel II]
G. Uncertainty
“No, I didn’t consider that at all, actually. I didn’t think about it. For me the safety of the baby had to come first. No, I didn’t see any benefit in it. No, they [the doctor/counsellor] didn’t bring up the advantages side and I didn’t ask about it.” [Non-participant Ppromexil trial]
“I don’t know if it’s really stressful, but we have talked about it a lot. You know, with my husband and also with a friend of mine in Rotterdam. And I have been very busy with it in my head, but whether it’s caused physical stress? I don’t know. Yes, I have thought a lot about it, because you can never be right. If he’d been born and there was something wrong and I hadn’t taken part in the study, then I would’ve thought: if only I had taken part in the study. And if he’d been born and I had taken part and there was something wrong, then I’d have thought: if only I hadn’t taken part in the study.” [Participant Apostel II]
“They [the doctors] also said, ‘We think it’s a very silly thing to say, and very strange for you, but we have to be honest: we don’t know. And I was lying all the time, thinking ‘I’ll see what happens’. Until that moment, when I thought, well, actually I felt I’d been left to my fate. You’re not lying there for nothing. They know it, they’ve studied for this. I’m sure they could tell me what direction it’s best to go in, but apparently they can’t. And that’s really tough. They could only give you certain facts. Well, not even that, really, just that research was there for a reason.” [non-participant Hypitat II]