The Release trial is an intrapartum randomised-controlled trial of umbilical oxytocin injection for the treatment of retained placenta. Retained placenta occurs after 2% of deliveries and is diagnosed when the placenta fails to deliver 30 minutes after childbirth. Due to its acute clinical context it has thrown up a number of ethical issues concerning informed consent. The consent pathway for the trial was developed in consultation with local and national consumer groups, local experts in the field of consent issues and the London Multi-centre Research and Ethics Committee (MREC). The issues faced during this process are detailed below, with examples of how the Release trial addressed them and points for consideration by other researchers.
Antenatal information
The provision of sufficient accurate information is an essential part of seeking informed consent. Indeed, when seeking consent the quality and clarity of the information given should be the paramount consideration [3]. For intrapartum trials it is not possible to fulfil all of the criteria above, especially that of time. Hence, there has been a move to provide information to all pregnant women antenatally, despite the fact that only a small number will be eligible to participate in a study. However, there is a conflict between promoting 'normality' in pregnancy and labour, and routinely presenting women with research information. For many women the risk of experiencing these adverse events is small and to present women with a detailed discussion of each complication's symptoms and management risks, unnecessarily detracts from labour as being a normal physiological process.
To date there have been no studies specifically designed to evaluate women's antenatal information requirements concerning obstetric complications and associated research. However, a study by Jackson and colleagues in Canada studied women's desire for information about risks associated with epidural analgesia [10]. The researchers used a questionnaire covering demographic data, epidural and consent information. Fifty six women who had requested an epidural were asked to give a score between 0 and 10 for the question 'risks should be discussed prior to labour'. The average score to this question was 8/10 (0 = least, 10 = most). The authors concluded that labouring women want to hear about all potential epidural complications, and for risks to be explained to them before labour. Although this study addressed information regarding risks associated with a treatment, specifically epidural analgesia, it may suggest that some women wish to be informed of potential risks associated with intrapartum research before they go into labour.
A prospective study of women's views by Lavender and colleagues explored aspects of childbirth that women perceived as being important and as contributing to a positive birth experience [9]. Women considered information to be an important factor contributing to a positive labour experience, with 154 (37%) feeling unprepared for labour because of either a lack of information or their own unrealistic expectations. Some women stated that they wished they had had more information antenatally. Those women who felt prepared, and who felt they had acquired adequate and accurate information were less likely to view their labour negatively. The nature of the information women would regard as adequate, or that they would like to receive antenatally requires further exploration.
For the Release trial antenatal information is provided through a variety of means. First, brief information is provided to women at the 'booking' visit at 9–14 weeks, in the form of an A4 information sheet in their case notes. This information provides an introduction to the study – what it is called, why it is being conducted, a brief overview of the technique being evaluated, and who to contact for further information. Additional information in the form of a 4-page tabloid-style brochure has also been distributed in antenatal clinics and is available on labour wards in the UK trial sites (figure 1). The purpose of this is to provide further details of who the study is organised by and how it is funded. It also provides further details of the technique being evaluated, advice on how to take part, contact details and pictures of the research team so as to develop familiarity. These sources of information are backed up with posters in the antenatal clinics and publicity in the local press.
All the above publicity is provided to raise awareness of the trial antenatally and give women the option of obtaining more information if they wish.
Web-based information
For each individual the requirement for information is different depending on their personality, time pressures, and interest. Some women will wish to know in advance every risk associated with pregnancy and the research being conducted to address those adverse events, while others may not wish to know about such risks prior to them arising.
A good medium to use for addressing differing information requirements is the internet. As a source of information, it allows a person to obtain as little or as much information as they wish, and to retrieve that in which they are interested.
In all of the Release study documentation available to women, reference is made to the study website to which women may turn to address their different information needs (figure 2). The website provides information of a varying nature; non-clinical and clinical, plus latest news items and downloadable resources including presentations and trial documents. It therefore provides a good source of information addressing questions of a various nature and level. However, there are limitations associated with the dissemination of research information via the internet, for example not all potential participants will have access to computers and, for smaller studies, the expense of setting up and maintaining a website may be prohibitive.
Information at the time of recruitment
Finally, there is the controversial issue of seeking consent while a woman is in labour. It may be argued that some women are unable to give their full attention to the details of a research study and to think carefully about the implications of becoming involved in the research while they are in labour. During this time women may be experiencing painful contractions, drowsy through the effects of opioids and anxious about the possibility of complications. In addition, many women may feel vulnerable. They may therefore be afraid of not complying with their carer's suggestions and may feel pressurised into giving their consent to participate in clinical research. As such, it is possible that a woman's competence to give informed consent during labour may be compromised [11].
In some trials of emergency treatments outside labour, researchers have sought retrospective consent [12, 13]. Whilst this may be suitable for trials in which the time period between diagnosis and need for randomisation is very short or the patient is clearly incapacitated, being in labour is not in itself an indication for doing this. Jackson and colleagues found that women in labour were as able to give informed consent as are other members of the patient population [10]. The investigators surveyed 60 women who were actively in labour without epidural analgesia, to assess women's ability to understand epidural risks during this time. They found that the women wanted to know about labour epidural analgesia and have all risks disclosed. The authors concluded that no anticipated variable (i.e. labour pain, anxiety, opioid pre-medication, duration of labour pain, desire for an epidural, previous epidural experience or level of education or age) correlated with a woman's ability to understand epidural risks, and that all of the women had at least a moderate understanding of the risks during active labour. A further study investigated the ability of women in labour to recall the risks of epidural, previously explained to them in labour [14]. This study also questions the assumption that women in labour lack the capacity to give informed consent. The recall of risks by women in labour was found to be similar to that of other patient groups, and did not appear to be affected by parity or the reported level of pain.
So if women can comprehend the research despite the stress of labour, do they feel pressurised to participate due to their vulnerable state? A study by Dorantes and colleagues, looking at the factors that influence women's decisions to participate in obstetric anaesthesia research, suggested that the environment, in which consent for obstetric studies was sought, was not coercive [15]. In this study, only one woman out of 166 consenters reported feeling pressurised to consent.
For the Release trial, these issues were addressed by consultation with consumer groups who provided valuable input from women's perspectives, addressing questions raised by the ethics committees during the process of protocol development. The result was a consent pathway (figure 3) drawn up by the University of Liverpool School of Reproductive and Developmental Medicine in collaboration with the North West Obstetrics and Gynaecology Clinical Trials Network (NWCTN), and representatives from local consumer groups.
When the diagnosis of retained placenta is made, 30 minutes following delivery of the baby, the trial may be discussed by the researcher in further detail with her attending midwife or doctor to ascertain whether it is appropriate to approach her, considering her emotional and physical state. Whilst this would be considered good research practice anyway, this role should be made explicit, with the primary carer acting as gatekeeper on behalf of the labouring woman, preventing unwanted disturbance and acting as advocate for her. If appropriate, the woman will then be provided with a more detailed information sheet, which is also available in Somali, Arabic, and Luganda, and which contains a flow diagram to facilitate understanding. This information builds upon that the woman received from the various sources antenatally. At this point, the doctor or midwife seeking consent, who will be fully trained in consent procedures, would confirm some level of understanding on the woman's part, by encouraging her to reiterate important points of the study. Only following this will formal written consent be sought.