Interpretation
This study followed RCOG guidance for taking consent for research in acute situations.3 The process of taking verbal consent with subsequent written consent and was found to be acceptable to women and birth partners. This reflects the information-giving process for taking verbal consent for clinical procedures, despite the fact that many obstetricians perceived that more detail was required for research. Women in this study however, believed they had been provided with adequate information with which to make a decision, even though there was not perfect recall of the exact information given. This differs from other studies where some women did not recall their involvement in research.4 This may be due in part to the fact that half the women in this study chose epidural for pain relief and therefore may not have experienced disorientation due to systemic analgesia. However, even women who chose opioid methods of analgesia were able to recall giving consent, if not the detail. The balance of information given was important; women did not want to be overwhelmed with information, rather they preferred to receive the key points on which to base their decision, reflecting the findings of others.12,13 In practice, information requirements are likely to vary between women, dependent on their individualised needs and situation at the time.2
The information needs of women appeared to be dependent on the evolving situation, with women in this study mostly not wanting prior information about the study. Whilst it is recognised that women do seek out information about pregnancy and birth,14 this may relate to normal process, rather than complications of birth or research. Women may be employing this as a strategy to preserve their plans for normality in labour and birth, with consideration of alternatives only when necessary. A systematic qualitative review by Downe (15)15 suggests that whilst women do not want interventions, they do want a safe birth; this may explain how and when women choose to interact with information and choices for care. Birth partners felt that women should have information in advance; however, they were less aware of potential complications of labour and birth.
In determining study participation, the relationship and degree of trust between the woman and the obstetrician seeking consent was paramount, reflecting previous findings (4, 13, 16, 17). In this study obstetricians also agreed the relationship was important and felt more comfortable discussing the study with a woman they had built a relationship with, rather than someone they had just met.
Communication was an important element in the consent process (9) and the verbal nature of the information delivery may have enabled the key points of the intervention to be highlighted in a concise and understandable way. However, this is dependent on the skills and equipoise of the clinician to ensure balanced information is given. Self-perceived clinical competence, team support and time factors are all elements which can affect information giving and clinical decision making in emergencies (18). Clinicians clearly felt less comfortable in gaining consent for research than for clinical care, despite being experienced in obtaining consent for emergency treatments. The additional training given in taking consent for research in these situations was welcomed by clinicians and may have increased study participation. This is an area to be considered for successful recruitment in studies using this approach to consent.
In an emergency intrapartum situation, time is critical, and it would be unacceptable to delay emergency treatment in order to discuss consent for research. Women in the COPE study, an ongoing randomised trial comparing two first line PPH medications, do not consider verbal consent to be approriate.19 For that situation, alternative consent processes are needed. For example, in the COPE study, no consent is taken but postnatal consent for use of data and follow up are requested the following day. In the first 161 recruits to that study only 4% were dissatisfied with this process of consent.19 By way of contrast, in this study the PPH Butterfly device was used as a second line therapy for those who continued to bleed despite initial oxytocin treatment. This gave a brief window of opportunity to discuss consent for the research. Despite being only a very short time period, it is similar to the time taken for use of standard therapeutic non-research interventions and the women in this study felt that it was adequate for them to give a response. The sensitivity and communication skills of the recruiting clinicians were critical in this situation, as was their training to exclude any woman who showed uncertainty about participating.