This qualitative descriptive study explored factors influencing recruitment to a pilot trial on the prevention of striae gravidarum, using semi-structured telephone interviews with 15 primigravid women. In keeping with a qualitative descriptive design and its ‘low-inference’ description [21], the findings have remained close to the original data and are relayed in common terms [21] through the themes and categories generated via the framework analysis method [33].
Our findings emphasise the importance of striae prevention for women during pregnancy. Many participants had already thought about stretch mark prevention at an early stage of pregnancy and had already planned to use a topical product to try to prevent them. This echoes previous research, where most respondents in a large survey in Ireland reported using a product to prevent or reduce stretch marks in pregnancy [15]. Many believed that they were better to apply a product to the skin during pregnancy (even it was not known to be effective) rather than not applying anything. They were not prepared to negotiate on anything that could increase their chance of getting stretch marks. This supports the views in the literature that many women are concerned by stretch marks [12], particularly because they do not completely disappear [35]. Moreover, although not a medical issue, these marks are a significant cosmetic issue for women [11, 36], commonly referred to as ‘disfiguring’ [7, 9, 10, 36]. Furthermore, they can cause distress to some women [2, 14]. Thus, women want to try to prevent them.
A range of anti-stretch mark products were chosen or in use by the participants, which concurs with other studies [1, 15]. Some products were more popular than others, which has also been identified previously [15]. Under the category ‘prior knowledge’, in the narratives we could see some of the influences on participants’ choice of product, for example, brand familiarity and perceived product quality. Natural or organic products were clearly important to some women. No evidence of these influences were uncovered in the literature. Women’s uncertainty on the relative effectiveness of their chosen product reflects the current status of knowledge on the effects of these products [7, 16, 36]. Finally, in relation to cost, some participants were prepared to spend more than others to get their product of choice. Although the amount of money spent by women is not widely reported in the literature, our earlier research showed that primigravid women are more likely to spend more money on anti-stretch mark products than multigravid women [15].
The influence of family and of advertising on participants’ choice of anti-stretch mark product is in keeping with our previous research, where 49.3% (n = 278) of respondents identified advice from friends in helping them choose a product, followed by 23% (n = 130) for product advertisement, 18.8% (n = 106) for advice from a family member and 14.7% (n = 83) from the internet [15].
The possibility of being randomised to the non-intervention or control group in the pilot trial was a significant barrier to participation and is reflected in the category ‘I want a choice’. Participants did not want to be allocated to the control group and not be able to use a product. Furthermore, some wanted to choose their own anti-stretch mark product. This suggests that some participants did not seem to understand trial design fully and this has been noted by others [20, 37]. Kenyon et al., [37] interviewed women about their experiences of being recruited to a trial on antibiotics in pre-term labour (ORACLE) and reported that some women seemed to have poor understanding of trial processes [37]. Similar points have also been made in non-maternity studies [38].
The issue that randomisation is a barrier to recruitment to research is reported by others. Ballantyne et al., [39] (p.480) report how some pregnant women when interviewed about their involvement in a randomised trial comparing a probiotic supplement versus a placebo (PiP study) in New Zealand, saw possible randomisation to a control group involving a placebo ‘as a burden or disadvantage’, although it was not the main barrier. However, they add how anecdotal evidence from staff revealed that one main reason for women not agreeing to participate in the trial was their wish to take a probiotic during pregnancy, which they would not have being able to do if randomised to the placebo group. While participants in our qualitative study were discouraged by the use of a non-intervention group, others have reported how women during pregnancy have said that they were less inclined to agree to placebo-controlled trials because of the uncertainty of receiving or not receiving an intervention considered advantageous [40]. Uncertainty around placebo use and randomised trials has also being identified by others [20, 41], and Rodger et al., [42] found that pregnant women identified fear of being randomised to the placebo group as a reason for non-participation. In addition, some participants in our study referred to lack of choice, which may be related to lack of control which was identified by some participants in a study which explored the factors influencing women’s decisions on participation in research during pregnancy [43]. Some women disliked the idea of randomisation due to its reliance on chance and were possibly discouraged from participating due to the chance element and lack of control with a trial design [43].
These issues are central to the concept of equipoise. Baker et al., [43] highlight how women must believe equipoise exists before considering to participate in research. It was evident in our study that some women did not believe equipoise existed. Most felt products worked. Distrust of equipoise has also been highlighted by Oude Rengerink et al., [20] in their qualitative case control study on barriers and motivators for pregnant women participating in Dutch trials. In addition, participants in our study thought that using any product was better than not doing anything and some also thought that the intervention product in the pilot trial was not as good as some of their known products despite not having evidence to support this view. Perhaps these participants needed clearer information on the study, as highlighted by Baker et al., [43]. Baker et al., [43] suggest that if study information is sufficient for trial participants there should be no doubt in relation to equipoise. They also advocate involving women in the development of study information to ensure it is presented in an appropriate manner. However, in our case it is unclear if this would have changed women’s decision not to participate.
Both randomisation and equipoise or uncertainty are integral to randomised trials. Randomisation is the foundation for ‘...testing the statistical significance of differences...’ between the intervention and control groups in relation to the trial outcomes [44] (p.155) while uncertainty, equipoise or ‘clinical equipoise’ in the context of the ‘community’ refers to the principle that there is no agreement as to which treatment is best [45]. Furthermore, randomisation is considered to be the most ethical means of assigning participants to study groups in the presence of clinical equipoise [46]. Notwithstanding this, these concepts have proven to be problematic for participants [47]. Research has shown that participants might either not understand or remember the information given to them on both concepts [47]. While acknowledging the complexity of the task of explaining randomisation, Robinson et al., [47] suggest focusing on its scientific advantages through a clear understandable explanation, while also helping potential participants to consider how the trial will advance knowledge on the topic. More recently, and related to the clear explanation suggested by Robinson et al., [47], is the need for some communications skills’ training for clinicians recruiting to clinical trials [45]. This recommendation arose from a study on how clinicians communicated equipoise to potential participants during recruitment and included both interviews with the clinicians and audio recording of the recruitment meeting. These findings may be beneficial in the context of future trials on the prevention of striae gravidarum.
Support for the second category identified under this theme: ‘trial requirements should fit with my routine’ is also evident in the trial by Ballantyne et al., [39] (p.480). In that study, the participants identified the main burdens to participating in research as being associated with the ‘inconvenience and time commitment’ involved. They wanted to know how the ‘time commitments ... would fit into their schedule’. This was consistent with our data. Furthermore, Ballantyne et al., [39] report how some women had said they had declined to participate in other studies during pregnancy where greater time commitment was involved. Similarly, time was a barrier in the qualitative study by Ayoub et al., [48] on recruitment and participation of pregnant women in research. They highlighted how having a balance between participation and other life demands was central in the decision to participate in research. Some of our participants said they were unable ‘to commit’ to the trial requirements, which resonates with Baker et al., [43] (p.65) who said ‘...issues, such as self-commitment..’ are central to deciding to participate in a study. The linkage between non or partial compliance with trial requirements and study results can be seen in other studies. For example, Ballantyne et al., [39] (p.479), report how the participants cared about the study outcome, which included being interested in the results and hoping that the ‘...study would show meaningful results’.
In relation to diary related issues and how smart phone based diaries were suggested by some participants to ensure compliance, caution is advised by Laughland & Kvavilashvili [49] (p.552) from their recent studies in the UK. They compared participant owned smart phone based diaries and paper diaries in three studies designed to determine if smart phones were associated with greater compliance and a higher number of entries compared to the paper diary. They found that those using their smart phone were compliant because they had diaries with them continually and completed their diary entry sooner; however, in all three studies ‘significantly fewer memory events were recorded in smart phones than paper diaries...’. They offer some suggestions for overcoming this challenge around sending reminders to participants using their smart phone and conclude how ‘participant-owned smartphone diaries will become the standard tool’ [49] (p.561).
In our study, some participants wished to see a better known product being investigated while some had a preference for organic products. We were using a common baby oil considered to be a hypoallergenic Paraben-free product. Baby oil tends to be chosen by a smaller proportion of women to prevent stretch marks in pregnancy but nevertheless continues to be some women’s choice [1, 8, 15] and, as with other products used by women, there is a lack of strong evidence of effectiveness from high quality trials [7] to support its use. Our participants also mentioned a product that has research to support its effectiveness, which may relate to some misunderstanding of randomised trials and the concept of equipoise as highlighted above or indeed the influence of product marketing. The suggestion for use of more organic or natural products is not surprising due to their attraction for pregnant women who increasingly request advice on natural remedies for the minor disorders of pregnancy [50].
Finally, we interpreted from the data that incentives may be useful but not a major determining factor in participation in a future study. Women’s decision to participate in research is often related to their belief in contributing to scientific inquiry [20, 39, 43], wanting to help others or the chance of a better outcome for their own pregnancy [37, 43]. For example, participants in the ORACLE study were influenced by the possibility of delaying pre-term labour [37]. While participants in the MAGPIE trial of prophylactic anti-convulsants for severe pre-eclampsia reported that participation was a means to getting the pharmacological treatment, which was otherwise unavailable to them and which they had been advised would prevent a seizure [51]. Some studies also refer to the concept of altruism [43, 48], which is often related to contributing to scientific inquiry and benefitting society and themselves [48].
Participants in our study were not over burdened by requests to participate in other research studies since becoming pregnant. We are not aware of any evidence on research demands on women during pregnancy but Close et al., [18] report how participation in another study was an exclusion criteria in their study due to the extra time and travel expense burden. Not being asked to join other studies was most likely related to the early stage of their pregnancy for participants in our study. Timing and how participants are approached are also important [19, 43]. Timing in particular has been identified as a factor for non-participation, as has being given ‘an overwhelming amount of information’ [20] (p.8). Information overload has relevance for our study due to recruitment to the pilot trial being at the booking visit when much other information is given to women, but this did not seem to be an issue in our study overall perhaps because the waiting times at the clinic allowed women adequate time to discuss the trial. Nevertheless, in other studies women have reported how a ‘conducive environment’ is important during study recruitment [43] (p.63) and antenatal clinics can be busy areas.
Our study has some limitations. The participants were from one geographical area and only included English speaking women. In addition, all participants had been invited to participate in a single trial investigating the effectiveness of a moisturising oil (Baby oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. However, a strength is that factors identified relate to actual decisions not to participate in a real trial rather than a hypothetical trial or trial scenario, and, as such, our findings may inform recruitment strategies in other similar trials. This focus on a real, rather than a hypothetical trial is in keeping with the plans for the Cochrane review of recruitment strategies for randomised trials which will be limited to real trials only in future updates [52].
