C-GULL Pilot (Recruitment and Consent)

• Research type

  Research Study

• Full title

  A Pilot Study to Inform Recruitment and Consent for taking part in longitudinal research in Maternity Settings

• IRAS ID

  280632

• Contact name

  Louise Kenny

• Contact email

  louise.kenny@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• Duration of Study in the UK

  0 years, 1 months, 25 days

• Research summary

  This is a pilot study to assess the feasibility and acceptability of recruiting and consenting women pregnant with their first child (primiparous) to the longitudinal birth cohort Children Growing Up in Liverpool. A mixed method approach using a quantitative and qualitative research component has been adopted. The study will invite primiparous women around the time of booking (12 - 16 weeks’ Gestational Age) at the Liverpool Women’s Hospital to take part in a short research interview. During the interview the women will be asked to review the participant information and associated consent form for the Children Growing Up in Liverpool study and provide their opinion on the study. Information will be obtained on the presentation, wording and acceptability of the participant material provided and the consent items. This information will be collected via open discussion, a review of consent responses and open and closed interview questions. The results from this pilot study will be used to inform the future design, in particular the consenting pathway of the Children Growing Up in Liverpool study.

  Summary of Results
  This pilot study aimed to assess the feasibility and acceptability of recruiting first-time pregnant women to the C-GULL longitudinal birth cohort, and to explore their views on the study design, patient-facing materials, and consent processes.

  Methodology: Eligible women (aged ≥16, first viable pregnancy, 12–16 weeks gestation) were approached by research midwives following their dating scan. A total of 33 women were recruited from 113 eligible participants (29% recruitment rate), with 28 completing qualitative interviews. Interviews were transcribed and thematically analysed.

  Recruitment Outcomes: Of the 113 women identified as eligible for the pilot study, 33 (29%) were successfully recruited, with 28 (85%) completing interviews. Nineteen women (17%) declined to participate, primarily citing time constraints or a lack of interest in research. The remaining 61 (54%) were non-contactable, often due to incorrect or unresponsive contact details.

  Key Findings
  Acceptability and Attitudes
  • Most participants found the study concept valuable and were motivated to contribute to research improving local health outcomes.
  • Strong regional pride was expressed; many were drawn to contribute due to the Liverpool focus.
  • All participants agreed to future contact and partner involvement, and 93% would be happy to participate in the main study.

  Study Materials and Consent
  • Information sheets were described as well designed and easy to understand.
  • However, several participants found the study’s overall aims insufficiently clear.
  • Concerns were raised about: Gifting of data and samples, DNA extraction, Use of linked civic data and International data/sample transfer.
  • Participants recommended additional, optional information leaflets about data linkage, DNA use, and long-term storage.

  Consent Preferences
  • Some participants suggested re-consenting postnatally and at specific milestones.
  • There was a preference for optionality in sample collection (e.g. ability to decline placenta or hair samples).
  • Consent regarding child data use in adolescence was also raised, with suggestions that re-consent should be obtained when the child reaches an appropriate age.

  Barriers and Considerations
  • A minority of participants expressed mistrust or discomfort regarding sample use and privacy, reflecting broader public sensitivity, particularly in Liverpool.
  • Concerns were noted around feeling judged when discussing lifestyle or socio-economic data.
  • Some participants misunderstood the nature of feedback they would receive (expecting individual health feedback).

  Operational Considerations
  • Proposed antenatal visits (two in total) were seen as acceptable.
  • Strong preference for community-based or remote appointments, especially postnatally.
  • Participants asked for clearer information on the frequency and burden of postnatal follow-up over the study’s duration.

  Operational Learnings from the Pilot
  • Average interview time: ~1.4 hours
  • Recruitment success was impacted by contact issues, suggesting improvements needed in pre-screening and communications.
  • Sample and data consent should remain flexible to ensure inclusivity.

  General Recommendations
  1. Revise participant-facing materials to include:
  • More tangible examples of study benefits and outcomes
  • Detailed information on DNA, data use, and international transfer
  • Clarified postnatal follow-up expectations
  2. Introduce additional, optional consent layers for:
  • Sample type preferences
  • Data gifting and overseas transfer
  3. Enhance recruitment by:
  • Considering earlier awareness (e.g., booking appointment, posters)
  • Offering appointments in community settings or virtually

  Conclusion
  The pilot confirmed feasibility and broad acceptability of the C-GULL study. Participants were generally positive and willing to engage, though highlighted specific areas for improvement in information provision, transparency, and flexibility around consent. These findings will guide refinements to optimise recruitment, retention and participant experience in the main study.
  

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  21/EM/0191

• Date of REC Opinion

  12 Aug 2021

• REC opinion

  Further Information Favourable Opinion