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

Sawyer, Alexandra; Chhoa, Celine; Ayers, Susan; Pushpa-Rajah, Angela; Duley, Lelia


Alexandra Sawyer

Celine Chhoa

Susan Ayers

Angela Pushpa-Rajah

Lelia Duley


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.

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

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.

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.


Sawyer, A., Chhoa, C., Ayers, S., Pushpa-Rajah, A., & Duley, L. (in press). Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study. Trials, 18,

Journal Article Type Article
Acceptance Date Aug 16, 2017
Online Publication Date Sep 9, 2017
Deposit Date Nov 7, 2017
Publicly Available Date Nov 7, 2017
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 18
Keywords Clinical trials, Ethics, Consent, Oral assent, Preterm birth
Public URL
Publisher URL


s13063-017-2149-3.pdf (686 Kb)

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