Perinatal Loss - Early Referral for Counselling (PEARL-C)

  • Research type

    Research Study

  • Full title

    Perinatal Loss - Early Referral for Counselling (PEARL-C): A Feasibility Randomised Controlled Trial

  • IRAS ID

    348672

  • Contact name

    Alexander Heazell

  • Contact email

    alexander.heazell@manchester.ac.uk

  • Sponsor organisation

    The University of Manchester

  • Clinicaltrials.gov Identifier

    NCT07494760

  • Duration of Study in the UK

    1 years, 6 months, 0 days

  • Research summary

    In 2022, there were 4 stillbirths and 2.9 neonatal deaths for every 1,000 babies born in England and Wales. Despite the frequency of perinatal deaths, currently, there is no consistent provision of perinatal bereavement counselling for parents after stillbirth. This single-centre study aims to determine whether a randomised control trial to evaluate perinatal bereavement counselling is feasible. It will provide essential information to underpin a larger study which will give a more definite answer about the benefit of perinatal counselling. The larger study will inform national clinical practice guidelines by providing evidence for policymakers and professionals to make recommendations about whether perinatal counselling should be offered following stillbirth or neonatal death. We will recruit mothers and partners from Manchester University NHS Foundation Trust on the delivery suite at Wythenshawe Hospital (where there is currently no perinatal bereavement counselling service). Parents will be eligible if they have experienced the death of a baby within the maternity setting at Wythenshawe Hospital. We aim for 13 participants to receive the intervention and 13 participants to be allocated to the control group. Participants allocated to the intervention and control group will receive usual bereavement care from the perinatal bereavement team at the hospital; parents allocated to the intervention group will also receive 6-8 sessions of counselling over a 3–4-month period from a trained bereavement counsellor. Participants will complete validated psychometric questionnaires about their levels of perinatal grief, psychological distress, depression, and quality of life which will be administered at 2 months postnatal (before counselling begins), at 7-9 months postnatal (after counselling ends), and 12 months postnatal (follow-up). We will also interview approximately 4 healthcare professionals who have been involved with delivery of the intervention/referrals during the trial about their experience of the trial. The study will last for 18 months.

  • REC name

    Wales REC 5

  • REC reference

    26/WA/0084

  • Date of REC Opinion

    30 Mar 2026

  • REC opinion

    Favourable Opinion