Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study

The Cord Pilot Trial was a randomised comparison of alternative policies for the timing of cord-clamping at very preterm birth [1‐3] at eight UK tertiary maternity units. The trial included two novel elements which may have influenced women’s experiences of participation. First, to allow deferred cord-clamping without delaying neonatal care for babies requiring resuscitation at birth, newborn life support at birth was provided with cord intact and thus also allowed women to share the first moments of their baby’s life [4, 5]. Second, so that high-risk women and babies could be offered the opportunity to participate, we developed a two-stage consent pathway (with oral assent before the birth and written consent after the birth) for use when birth was imminent [6, 7]; this pathway was used for almost one third of recruitment [3].

Randomised trials are the ‘gold standard’ for evaluation of healthcare interventions. Understanding the experiences of women recruited to trials during pregnancy is especially important as they are also making a decision on behalf of their unborn child [8]. Conducting trials in stressful circumstances, such as when birth is likely to be very preterm, is challenging. This is particularly so when time for offering participation is limited; for example, when birth is imminent [9]. Better understanding of women’s experiences may help improve the design of trials and their relevance to the participants, thereby minimising potential barriers to participation, improving the experience of participating and improving recruitment and retention.

This paper reports the views and experiences of women about participating in the Cord Pilot Trial, based on self-completed questionnaires up to 1 year after the birth.

The Cord Pilot Trial compared cord-clamping after at least 2 min and providing immediate neonatal care, if needed, with cord intact (deferred clamping) with clamping within 20 s and neonatal care after clamping (immediate clamping) at very preterm birth (< 32 weeks gestation) [1, 2]. Initially, the objective was to assess the feasibility of conducting a large, multicentre, UK trial and, as feasibility was demonstrated, recruitment continued whilst funding for the full trial was sought. The trial closed when the funding application was unsuccessful [10]. Throughout the planning and conduct of the trial, we worked with the National Childbirth Trust and Bliss (a UK-based charity for babies born prematurely or sick) for a strong parent perspective.

Posters about the study and summary information sheets were available in antenatal clinics and on antenatal wards. Women at risk of very preterm birth were invited to participate; if they accepted they gave written consent. Eligibility and willingness to participate were checked before randomisation, which was during labour or at caesarean section. If birth was imminent and the attending clinician felt it appropriate, women were offered a brief description of the trial and offered participation (oral assent). Those who gave oral assent were then randomised. After the birth, these women had an opportunity to discuss the study in more detail, and were invited to give written consent for participation in follow-up. This two-stage consent pathway was developed in discussion with the National Childbirth Trust and Bliss, to be used only when there was insufficient time for the usual consent process, giving these women the opportunity to participate [1].

For follow-up, women were asked to complete two similar questionnaires, the first between 4 and 8 weeks after giving birth, the second at 1 year. We initially planned that the first questionnaire would be posted to the woman’s home 6 weeks after the birth, but this often coincided with discharge of the baby which was not a good time for the women to receive it. Therefore, we changed this and if the baby was still in hospital at age 4 weeks, the research midwife/nurse gave the questionnaire to the woman when she was visiting. If the baby was not in hospital at 4 weeks, we posted it to her 8 weeks after the birth. If the baby died or was stillborn, covering letters and the questionnaires were adapted appropriately. Before sending the questionnaire at 1 year, we checked the baby’s status with the recruiting site, or with the general practitioner if the family had not been seen recently at the site. We then posted the questionnaire, along with a birthday card for the child (if appropriate). A stamped addressed envelope was provided to return completed questionnaires. If there was no response, we sent a postal reminder after 2 weeks. If there was still no response after another 2 weeks, we telephoned the woman and offered the opportunity to complete the questionnaire over the telephone. If no telephone number was available, we sent a second postal reminder.

Both questionnaires included three questions about the women’s experience of participating in the trial, which had been previously used for a trial involving women with pre-eclampsia [11]:

Responses to other questions about symptoms of anxiety or depression, satisfaction with care at birth, and breastfeeding/expressing are reported elsewhere [12].

Overall, 261 women were randomised between March 2013 and February 2015, six of whom were excluded as they gave birth after 35^+ 6 weeks and one withdrew the use of their data, leaving 254 women for the analysis of outcome at hospital discharge (Fig. 1) [3]. A further six women were excluded from follow-up after discharge: three for whom we had oral assent only and so consent for follow-up was not available, and three whose baby died before discharge and the site advised us not to contact them. Four women were sent the 1-year questionnaire only, as their baby died and the site advised us not to send the first questionnaire.

Of 244 women sent the first questionnaire, four did not complete it and asked not to be contacted again, another completed it but asked for no further follow-up. Overall, 186 of the first questionnaires (76%) were returned (79% deferred clamping, 74% immediate clamping) (Fig. 1). For one woman the site advised us not to send the second questionnaire due to safeguarding issues. Two hundred and forty-two women were sent the second questionnaire at 1 year, and 133 (55%) responded (66% deferred clamping, 43% immediate clamping). Although the questionnaires asked about the women, a few were completed by someone else on their behalf (six of the first questionnaires and five of the second). For six of the first questionnaires and three of the second, it was not stated who completed the questionnaire.

For both questionnaires, characteristics at trial entry for the women who responded were similar between the allocated groups (Table 1). A higher proportion of women allocated deferred clamping responded than those allocated immediate clamping, and this was more marked for the second questionnaire at 1 year. Factors in response were similar in both groups and have been described in detail elsewhere: response was higher for women aged 30 years or older at the time that they gave consent, and for those recruited during their first pregnancy lasting 20 weeks or more [12]. Response for the first questionnaire was similar, although slightly lower, for women recruited using the two-stage consent pathway (69%) and the usual one-stage consent pathway (78%). Response for the second questionnaire was very similar for the two consent pathways (56% for usual one-stage and 53% for two-stage).

Results of this questionnaire study provide insight into women’s experiences of participating in the Cord Pilot Trial. The response rate was higher for the first questionnaire, than for the second at 1 year; and at 1 year the response was much higher for those allocated deferred clamping (66% and 43%, respectively). Responses to the questions were similar at the two times frames however. Overall, women were positive about the trial and their participation, and only a few said that they would not participate again. There were no clear differences in response about participating again according to any pre-specified factors, including the consent pathway, except that a greater proportion of women allocated deferred clamping indicated that they would definitely participate again than those allocated immediate clamping. The main reasons that women gave for their positive response were altruistic (benefits to others, importance of research), benefits to the baby, and no risk to the baby. These are in line with what has been reported for other studies recruiting women into trials during pregnancy [15, 16]. Things women said they liked about the trial included detailed information and clear explanations of the study, and the caring and friendly staff. A greater proportion of women allocated deferred clamping made comments indicating that they thought that the health of their baby was better as a result of joining the trial.

For this trial, women were approached and invited to participate at a difficult time as they already knew their baby was likely to be born too early; and for some, birth was imminent. Therefore, it is unsurprising that some women said that they would prefer this approach to have been earlier and that they would have liked more information, albeit recognising that it can be hard to know when. This comment was made by women recruited using both the usual consent pathway and the two-stage pathway. Other studies have also reported that women would like information earlier. For example, one study exploring women’s experiences of an intrapartum trial in an emergency setting found that whilst women recognised that information provided during pregnancy may not be personally salient they thought that women should be given the choice whether or not to engage with the material [17]. However, in comparison, staff were concerned that giving information to all women would be an ineffective use of time and resources, and potentially distressing to many women to whom it would not be relevant [17]. Furthermore, on the second questionnaire at 1 year, some women wrote that the first questionnaire could have been timed better when it was less hectic, and that they would have liked to have received more updates about the progress and results of the trial. In a qualitative study exploring parents’ reactions to trial results, parents said that feedback was important to them because it provided further information and clarity, helped them to remember an emotional time, and acknowledged their important contribution to medical research [18]. Therefore, for a trial such as the Cord Pilot Trial where the follow-up continues long after the intervention has been completed, keeping participants up to date on trial progress and when they might expect to know the results of the trial, is particularly important. Consistent with previous research [19, 20], responses from several women suggested a misunderstanding of the randomisation process; for example, saying ‘… it (being in the trial) turned out not to even be worth it because we didn’t get the right envelope’.

Feedback from women who completed these two questionnaires is reassuring that the study was appropriately designed and relevant to those who participated. This is reflected in the higher than anticipated recruitment and good retention of participants, both of which are likely to be improved by well-designed studies integrated into existing health services that minimise inconvenience to participants [21, 22]. Nevertheless, women’s responses suggest issues for researchers to consider when planning future similar studies. For example, ways in which information about the trial might be made available earlier; providing additional information about the trial and/or the background condition that is available for those women who wish to access it; and providing more updates about the trial to participants.

A strength of this study is that we received responses from a high proportion of participants in the trial. Using three questions added to a follow-up questionnaire is simple, cost-effective, and time-efficient. Although the traditional method for assessing participants’ views is in-depth qualitative interviews, the responses to the questions used in our study are comparable with responses from studies using qualitative interviews [23]. Limitations of our study are that we do not know whether women who did not complete the questionnaire had a different experience of the Cord Pilot Trial. Also, women who were offered participation but declined or were not recruited for other reasons may have had different experiences and views. The experiences reported in this study may not be applicable to all parents who enrol their preterm baby into a clinical trial. Our results are based on a single trial, and other factors may be more or less important in trials with different risk and benefit profiles.

Overall, women were positive about their experiences of participating in the Cord Pilot Trial, with only a small number negative about their participation. Women cited the importance of research, the benefits for their baby and benefits to others as reasons for participating. Women were positive about the level of information and explanations and the friendly and caring staff in the trial. Nevertheless, women had suggestions for how to improve the study. For example, some women would like to have received more information about the trial earlier in labour or during pregnancy; others would have liked more updates about progress. Some of the feedback also reflects misunderstanding about randomisation, a common finding in similar studies, suggesting that research is needed on how best to communicate this with potential trial participants. Responses also highlight the importance of communicating trial results to participants. This study demonstrates the value of simple, low-cost questionnaires to assess participants’ views of being in a randomised trial.