ArticleClinical trials (London, England)2026
Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial.
Article in Clinical trials (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
- Commentary: Multi-stage consent for time-sensitive clinical trials.Clinical trials (London, England) · 2026Article
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8 authors.
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Abstract
backgroundIntrapartum research (occurring during labour and birth) presents challenges to successful recruitment to clinical trials. These include limited time for discussion, decision-making for two (mother and baby), heightened emotional states (pain, anxiety and/or fatigue) and clinician hesitancy to discuss research in this setting. In the context of the Baby head ElevAtion Device Feasibility Study, where the event of interest (caesarean section at full dilatation) is both rare (fewer than 3% of all births) and unpredictable, we undertook a mixed-methods evaluation of the two-stage consent process: (1) abbreviated intrapartum consent and (2) full postpartum consent. The aim was to explore whether abbreviated intrapartum consent was acceptable to patients and clinicians.
methodsEligible patients approached at full cervical dilatation (10 cm) to take part in the Baby head ElevAtion Device Feasibility Study were invited to complete a face-to-face survey of their experience of consent within 3 days after birth. We sampled those who consented and those who declined the study. Clinicians working at recruitment sites were invited to an individual semi-structured interview. Qualitative data were analysed using reflexive thematic analysis.
resultsOver 12 months, 69% (128/186) of eligible patients consented to the Baby head ElevAtion Device Feasibility Study; 87% of consenters and 66% of decliners completed a follow-up survey. Most survey responders (78%) and clinicians found abbreviated intrapartum consent acceptable. Three themes shaped patient decision-making: perceived benefits, trust in healthcare, and feeling overwhelmed. Those who declined often wished they'd had more time or earlier information. Clinicians found the two-stage consent process feasible and appropriate for low-risk interventions, although time pressures and communication challenges affected consent quality. Many saw the model as respectful of autonomy and potentially useful for future intrapartum research.
conclusionOur findings suggest that the two-stage consent process for this intrapartum study was acceptable to both patients and clinicians. We propose this as a useful consent model for peripartum studies where the clinical situation occurs infrequently, the intervention being studied is low risk, and where opt-out or deferred consent is not available.
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