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

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.

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PID https://www.doi.org/10.6084/m9.figshare.c.3875782.v1
PID https://www.doi.org/10.6084/m9.figshare.c.3875782
URL http://dx.doi.org/10.6084/m9.figshare.c.3875782
URL http://dx.doi.org/10.6084/m9.figshare.c.3875782.v1
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Author Sawyer, Alexandra
Author Celine Chhoa
Author Ayers, Susan
Author Pushpa-Rajah, Angela
Author Duley, Lelia
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Collected From Datacite
Hosted By figshare
Publication Date 2017-01-01
Publisher Figshare
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Language UNKNOWN
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keyword FOS: Health sciences
system:type other
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Source https://science-innovation-policy.openaire.eu/search/other?orpId=dedup_wf_001::cc2c08f2498b6b743d662507db805046
Author jsonws_user
Last Updated 20 December 2020, 03:28 (CET)
Created 20 December 2020, 03:28 (CET)