Abstract
OBJECTIVE: The World Maternal Antifibrinolytic (WOMAN) Trial was the first in the UK to use the option of waiver of informed consent at the time of an obstetric emergency. This qualitative study aimed to investigate participants' views of the acceptability of the recruitment methods used. DESIGN: Qualitative study using in-depth interviews with women who did and did not give consent at the time of their recruitment to the WOMAN Trial. SETTING: Highest UK recruitment site for the WOMAN Trial (129/569). Interviews were conducted in participants' homes. POPULATION: About 40 of the 129 women who were recruited to the WOMAN Trial at one UK site were invited to take part, 15 women were interviewed. METHODS: Qualitative, interview study. MAIN OUTCOME MEASURES: Facilitators and barriers to successful recruitment during obstetric emergencies. Guidance for future researchers. RESULTS: Findings revealed that what is important is not so much the consent process used or a signature on a form, but the way in which consent is obtained. Clinicians who successfully negotiate consent to research during childbirth emergencies engage in a 'humane choreography' of words and actions. This emphasises the importance of prompt decision-making and treatment, while respecting the woman's personal situation and experience. CONCLUSIONS: Our findings do not support a single pathway to consent in the context of an obstetric emergency. Women understand that consent to research in an emergency is complex. Clinicians' skills in considering the clinical, ethical, and emotional aspects within the context of the clinical emergency can hamper or promote women's satisfaction. TWEETABLE ABSTRACT: Study reports on women's views of consent to research in an obstetric emergency. PLAIN LANGUAGE SUMMARY: Why and how was the study carried out? We undertook this study to find out what women thought about being included in a research study called the WOMAN Trial at the time they were being treated for heavy bleeding after giving birth. Some women had been asked if they wanted to be a part of the research at the time they were bleeding. Others were asked later, after they had recovered. We conducted interviews with 15 women who had been involved and asked what they thought about the way they had been asked, their preferences and ideas for improvements in future similar studies What were the main findings? Women understood how difficult it was for their doctors and midwives to ask them about the research study. They were pleased to have been included in the research and were mostly happy with the way they gave consent. Women's views were similar whether they were asked about the research at the time of the bleeding or after they had recovered. The most important thing was that doctors and midwives carefully thought about the situation the woman found herself in and how this might make her feel, so they could tailor their approach accordingly. What are the limitations of the work? This study only involved women from one hospital. The WOMAN Trial included women from many areas of the UK and other countries around the world. We do not know how their experiences or views may differ. What is the implication for professionals? Careful use of actions and words by birth attendants was the difference between a good or bad experience for the woman and her family. This is an important skill that could be developed as part of professional training.