Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Sawyer, Alexandra and Chhoa, Celine and Ayers, Susan and Pushpa-Rajah, Angela and Duley, Lelia (2017) Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study. Trials, 18 . p. 422. ISSN 1745-6215

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Abstract

Background

The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women’s views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial.

Methods

We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis

Results

Twenty-three women who gave either written consent (n = 18) or oral assent followed by written consent (n = 5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women’s minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women’s understanding of the trial and intervention, regardless of the consent pathway.

Conclusions

Overall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited.

Trial registration

ISRCTN Registry, ISRCTN21456601. Registered on 28 February 2013.

Item Type: Article
Keywords: Clinical trials, Ethics, Consent, Oral assent, Preterm birth
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Identification Number: 10.1186/s13063-017-2149-3
Depositing User: Eprints, Support
Date Deposited: 07 Nov 2017 13:32
Last Modified: 08 Nov 2017 08:07
URI: http://eprints.nottingham.ac.uk/id/eprint/47932

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