Trial reportTrials2017
Clinicians' views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed.
- Deferred consent in emergency obstetric research: findings from qualitative interviews with women and recruiters in theBMJ open · 2022Trial
- Trial
- Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences.Archives of disease in childhood. Fetal and neonatal edition · 2021Trial
- Trial
- Trial
- Parent views on a two-step consent process used in emergency neonatal research in the delivery room in Eastern Uganda.BMC medical ethics · 2026Article
- How to optimise the use of innovative invasive devices: considerations for feasibility studies.Pilot and feasibility studies · 2026Article
- Women's and midwives' views on the optimum process for informed consent for research in a feasibility study involving an intrapartum intervention: a qualitative study.Pilot and feasibility studies · 2023Article
- Recruiters' perspectives of recruiting women during pregnancy and childbirth to clinical trials: A qualitative evidence synthesis.PloS one · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundThe Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians' views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth.
methodsThis was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis.
resultsSeventeen clinicians who had either offered usual written consent only (n = 6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n = 11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a "need to know" basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent.
conclusionsThe two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies, although some concerns were raised about the practicalities of obtaining oral assent.
trial registrationISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.