Approaching people for participation in a clinical trial during a clinical emergency can be challenging for both clinicians and patients. We developed a two-stage consent pathway to offer women having a very preterm birth the opportunity to participate in the Cord Pilot Trial.

The two-stage pathway included oral assent, followed by written consent, for women when birth was imminent, and was used to recruit almost a third of the total women recruited. In collaboration with Professor Susan Ayers, City University, we conducted qualitative interviews to assess the views and experiences of clinicians and women of the two consent pathways in the trial.

This approach has since been included in guidance from the Royal College of Obstetricians and Gynaecologists. We are also using the two-stage pathway in the FEED1 trial and further work about this approach has since been published. For further information about this approach, contact Eleanor Mitchell.

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