What women think about consent to research at the time of an obstetric emergency: a qualitative study of the views of a cohort of World Maternal Antifibrinolytic Trial participants

• Published in: BJOG : an international journal of obstetrics and gynaecology 2018-12, Vol.125 (13), p.1744-1753
• Main Authors: Houghton, G, Kingdon, C, Dower, M, Shakur‐Still, H, Alfirevic, Z
• Format: Article
• Language: English
• Subjects: Adult; Antifibrinolytic agents; Biomedical Research; Birth; Bleeding; Childbirth & labor; Clinical decision making; Consent; Data Accuracy; Decision Making; Emergencies; Emergency medical care; Female; Humans; Informed Consent; Interviews as Topic; Intrapartum Care; Medical research; Midwifery; obstetric emergency; Obstetric Labor Complications - psychology; Obstetric Labor Complications - therapy; Obstetrics; Patient Participation - psychology; Patient Selection; Pregnancy; Qualitative research; Women; women's views; Womens health; Young Adult
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/1471-0528.15333

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 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 pl