Trial reportTrials2017
Women's views and experiences of 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 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis.The Cochrane database of systematic reviews · 2020Pooled it
- The acceptability and feasibility of a randomised trial exploring approaches to managing impacted fetal head during emergency caesarean section: a qualitative study.BMC pregnancy and childbirth · 2023Trial
- 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
- Randomised trial of cord clamping at very preterm birth: outcomes at 2 years.Archives of disease in childhood. Fetal and neonatal edition · 2020Trial
- Trial
- Cord pilot trial, comparing alternative policies for timing of cord clamping before 32 weeks gestation: follow-up for women up to one year.BMC pregnancy and childbirth · 2019Trial
- Parent views on a two-step consent process used in emergency neonatal research in the delivery room in Eastern Uganda.BMC medical ethics · 2026Article
- Facilitators and barriers in obtaining informed consent for neonatal research: a scoping review.European journal of pediatrics · 2026Article
- Recruitment Techniques Used for Clinical Trials and the Potential Impact of Nudges: Qualitative Interview Study with Recruiters.Journal of empirical research on human research ethics : JERHRE · 2025Article
- Emergency Verbal Consent for Intrapartum Research: A Grounded Theory Study.BJOG : an international journal of obstetrics and gynaecology · 2025Article
- Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia.Archives of disease in childhood. Fetal and neonatal edition · 2023Article
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. 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.
methodsWe 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.
resultsTwenty-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.
conclusionsOverall, 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 registrationISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.
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