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July 24, 2026TrialsOpen Access

Considering the timing and appropriateness of trial consent during childbirth: a secondary analysis from the qualitative process evaluation of the ROTATE trial

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Authors

EMEleanor MolloyJNJ. NichollsDPDawn Parris

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Overview

Secondary analysis investigates informed consent challenges during childbirth in a clinical trial, highlighting ethical implications.

Key Points

  • The research aims to explore the challenges of gaining informed consent during late-stage labor in a clinical trial setting.
  • Secondary analysis of qualitative data from semi-structured interviews with women (n=9), birth partners (n=3), and healthcare professionals (n=11).
  • Analysis utilized codebook thematic analysis to identify themes regarding trial consent processes.
  • Investigation of the two-stage consent process involving verbal assent and written consent post-birth.
  • Participants reported that discussing trial entry during late-stage labor adds complexity and stress.
  • The two-stage consent process was viewed as acceptable and pragmatic by parents and healthcare professionals.
  • Early information and layered discussions about participation facilitated better recall and decision-making under stress.

Cite This Study

Molloy et al. (2026) studied this question.

synapsesocial.com/papers/6a6301d3395161722cd164echttps://doi.org/10.1186/s13063-026-09881-3
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