Impacts on practice
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Recruiting mothers approaching weaning stage and second-time mothers in clinical lactation studies is likely to lead to recruitment compared to mothers at early lactation stage and first-time mothers.
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The provision of home visits, where possible, may improve the recruitment of lactating women in clinical lactation studies.
Introduction
Aim of the study
Ethics approval
Methods
Study sample
Data collection and recruitment
Understanding of “clinical trial”
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1. What comes to mind when you hear the word: clinical trial? |
Breastfeeding women’s participation in a clinical trial
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2. Would you be willing to participate in a clinical trial whilst you are breastfeeding? |
Explore reasons |
3. What would make you feel more comfortable about participating in a clinical trial whilst breastfeeding? |
4. What barriers do you think would keep you from participating in a clinical trial whilst breastfeeding? |
Perceptions of information flow regarding proposed DOACs clinical lactation study
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(A PIL of the proposed DOACs clinical lactation study was given to participants prior to discussion; They were given 5 min to read) |
5. What comes to your mind, when you read the information sheet for the proposed study? |
Generate discussion |
Suggestion to the proposed DOACs clinical lactation study
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6. What would you say are things that would improve the proposed study? |
7. Would you be willing/interested to participate in the proposed study if you were eligible to participate? |
Explore reasons
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Data analysis
Results
ID | Maternal age (range in years) | Education level | Employment | Annual income from employment | Current infant age (months) | Current breastfeeding regime |
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A1 | 26–35 | Post-graduate | Full-time | > £60,000 | 4 | Breast only |
A2 | 36–45 | Post-graduate | Full-time | > £60,000 | 4 | Breast only |
B1 | 26–35 | College | Full-time | > £60,000 | 3 | Breast only |
B2 | 36–45 | Post-graduate | Full-time | £11,500–£31,999 | 7 | Breast only |
B3 | 26–35 | Post-graduate | Full-time | £32,000–£59,999 | 7 | Breast with occasional supplementa |
B4 | 26–35 | High school | Full-time | £32,000–£59,999 | 2 | Breast with supplement at every feed |
B5 | 36–45 | College | Full-time | £32,000–£59,999 | 5 | Breast only |
C1 | 26–35 | Post-graduate | Un-employed | < £11,500 | 13 | Breast only (started to add solid food) |
Perceptions of “clinical trial”
Decision-making process
Women’s decision-making was also influenced by the stage of lactation. The majority of mothers (N = 7) appeared to be more comfortable with participation towards the ‘weaning’ stage of breastfeeding:I was constantly asking them (the doctors)…All the research I came across online, pointed towards it being alright and also, I knew other breastfeeding mums that were on precautionary doses of enoxaparin following caesareans so it’s quite standard that people take. So, I was reassured. (FG3, C1)
Most women (N = 7) felt more relaxed to make decision with their second child:It’s not a crazy idea to ask women who are getting towards the end of their breastfeeding journey (to take part in clinical trials). Then you wouldn’t have to worry about having to breastfeed or trying to maintain a supply over the night feed. (FG1, A1)
In general, all mothers expressed that decision-making ultimately depended on weighing up the pros and cons from clinical trial participation.I think I am more relaxed the second time around and I feel like as long as I’ve got milk brilliant and then let’s go and if it stops then go with the bottle and you know he might not take it to start with but we will manage. (FG2, B2)
Motivations for clinical trial participation
Another significant motivation was the appreciation of healthcare providers who provided good care to mothers in the past. Mothers in FG2 discussed how the good care they received from the haematologists at King’s College hospital would motivate them to participate, whereas they might not be that motivated if asked by a research team who they were not familiar with:I would absolutely jump at the chance (of participating in the proposed study) because I know for a second baby I would need to inject from day one, …so to take a pill instead would be so much easier. (FG3, C1)
Mothers in FG1 also regarded financial incentives as important features through participation. As one mother indicated:I wanted to help because I had a really good experience with … and … and thought they really helped me out and I would like to do something. Whereas maybe, I don’t know it sounds a bit selfish really, someone I didn’t know, the health visitor I wouldn’t really be interested in a trial just because you know …that team (the research team of the proposed DOACs lactation study) was really good so I would like to do something if I can to help them out. (FG2, B4)
Incentives covering child care cost were also reported as being important by several mothers (N = 4) across the groups.I’m not sure how many women would do it unless there was a financial motivation. (FG1, A2)
Barriers for clinical trial participation
Furthermore, participation was influenced by factors associated with lactation. All mothers reported that they would not interrupt breastfeeding their infants for participating in a clinical trial during the early lactation stage, unless they had a life-threatening condition which required the test drug. They were aware of the benefits of maintaining breastfeeding and believed that milk supply would be reduced by interrupting breastfeeding:I’d be slightly concerned going into a clinical trial in case there were adverse effects, especially if it’s, like, on a baby. (FG1, A1)I think I definitely feel more risk adverse since having children and you have to look after yourself for their sake. (FG2, B2)The baby would always come first. (FG3, C1)
Despite the fact that a pump could be used to maintain breastfeeding during a clinical trial, a number of mothers mentioned that infants may refuse to bottle feeding and refuse to take frozen milk. Also, some mothers felt uncomfortable using a pump. A mother indicated that her breastfed infant would not drink the milk if it was frozen or if it had been stored in advance as “when I tasted my breast milk it was horrible”. (FG1, A2)Those first few weeks where you’re trying to get to grips with the breastfeeding, it can be very difficult, so it’s having the support there for the mother. Because it’s tricky to be able to do the breastfeeding in the first place, and then to sort of put that in with the trial as well. (FG3, C1)
Concerns on childcare whilst participating in a clinical trial were also frequently mentioned (N = 7), especially for those who had no close families around and had more than 1 child:I think a lot of it happens at around six months, because then that’s when you’re more likely to wean the baby on to food. And so you’re giving them different things anyway, so then that feels like a natural time to start introducing formula. But that’s also when they start to get more distracted. So he’d pull off when we were out and about and look around and it was just hard to try and make him feed whilst he was facing my breast, it was almost impossible. So giving him a cup of milk was a lot easier. (FG1, A2)
Practicalities from participation were also significant barriers, such as the pressure of time, accommodation in clinic, over-night stay and disincentives. Some mothers in FG1 and FG2 (N = 2) indicated that the pressure of time was a key barrier for their participation. A common negative aspect reported by all mothers was that the over-night stay brought inconveniences due to concerns on infants’ need for breastfeeding at night:I don’t have any family nearby, so it’s quite a big problem. (FG2, B5)
Other barriers reported were the health status of participants, untrustworthy study researchers, and having a family to care. Some mothers (N = 5) expressed that healthy volunteers would be less interested in clinical trial participation because they could not receive health benefits from participation and would be more concerned about safety:When she was in a particularly bad mood, I was just feeding her for comfort and she was falling asleep on my boob. Which I wouldn’t normally do, but she was just so miserable otherwise and I guess if you can’t give them that comfort during some difficult times that would be really hard. (FG1, A2)
I wouldn’t want to take even a small chance that in the future they could potentially find a problem, and its different if I had a medical condition and this might be of benefit to you then I would probably be more interested than if I was just a healthy volunteer. I wouldn’t want to gamble even a small amount. (FG2, B4)
Suggestions for the proposed clinical trial
If they were required to stay in the research site over-night, the majority of mothers in FG1 and FG2 (N = 5) suggested having the infant accompany during the stay and the provisions of a silent, child-friendly environment and convenient facilities, whereas other mothers preferred staying without infants when towards the ‘weaning’ stage of breastfeeding. Some mothers (N = 4) suggested childcare support from researchers or incentives covering childcare.I think that would just take away travel time and there would be more resources for you and I think it would make it easy of women participating who can’t sort out the practicalities. (FG2, B2)
Furthermore, the majority of mothers (N = 7) expressed a preference for real-time results in terms of drug concentration in their milk, and follow-up procedure, before restarting breastfeeding to reassure themselves that there was no chance of infants being exposed to the test drug:Pumping is a very weird experience and a strange thing to do and something I don’t think probably want…the amount of milk you’ll want could probably be hand-expressed. (FG1, A1)
Some mothers (N = 4) suggested that second-time mothers and mothers who had used pumps should be actively recruited:If you could run tests on the breast milk, and just say for example these are the results during the study, these are the results after, and the results before, so you know there’s absolutely nothing in the system, then you would continue breast feeding. (FG3, C1)
Most mothers (N = 5) seemed to be positive towards participation in the proposed study if they were motivated enough. Although several mothers (N = 3) were still concerned about their infants refusing to have pump milk or bottle feed, their attitudes would change if they were asked to participate towards the ‘weaning’ stage. One mother said:You’ll get a greater uptake from women who are already expressing or rather that will just be more likely to be more successful with women who are happily already pumping. (FG1, A1)
For me personally that you came to see me at six months, I would take part in it. (FG3, C1)