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NCT Number: NCT07494760

A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experienced a Perinatal Death

The goal of this feasibility randomised control trial is to determine if a trial to evaluate perinatal bereavement counselling for parents who have experienced a perinatal death is feasible. The main question it aims to answer is:

• Is a trial to evaluate access to perinatal bereavement counselling feasible?

Researchers will compare the intervention group (parents who have received counselling) to the control group (parents who have not received counselling) to see if there are differences in measurements of parents' grief and psychological symptoms.

* 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 receive counselling * Parents will complete validated psychometric questionnaires about their levels of perinatal grief, psychological distress, depression, and quality of life * Parents in the intervention group will be asked a series of open-ended written questions about their experience of participating in the trial * Healthcare professionals who have been involved with delivery of the intervention/referrals will be interviewed about their experience of the trial.

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Key information

Conditions

Stillbirth Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Grief Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Psychological Urogenital Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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. The investigators will recruit mothers and partners from Manchester University National Health Service (NHS) Foundation Trust on the bereavement suite on the birth centre 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. The investigators 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). Parents in the intervention group will also answer (in writing) a series of open-ended questions about their experience of engaging with the trial on their 7-9 month questionnaire. The investigators 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women and partners of women who have had a late fetal loss (from 16 weeks), stillbirth or neonatal death within the maternity unit at Wythenshawe Hospital.
  • For the qualitative interviews, healthcare professionals who have been involved with referrals to the intervention and/or the delivery of the intervention

Exclusion criteria

  • Less than 16 years of age
  • Anyone who lacks the capacity to consent
  • Inability to read English (interpreters will be provided for counselling sessions and interviews if needed).

Treatment and study plan

Bereavement Counselling

Other

Bereavement counselling for 6-8 sessions over a 3-month period beginning 3-4 months after a perinatal death

Usual bereavement care

Other

Routine hospital bereavement care: regular phone calls, face-to-face meetings, access to bereavement resources via Padlet, invitations to coffee mornings, information about SANDS (Stillbirth and Neonatal Death Society) groups, and referrals to apps to access support

Primary outcomes

  1. Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)

    Time frame: Baseline

    Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  2. Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)

    Time frame: 7-9 months postnatal

    Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  3. Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)

    Time frame: 12 months postnatal

    Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  4. Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)

    Time frame: Baseline

    Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013). 0 (Not At All) to 4 (Most of the Time). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  5. Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)

    Time frame: 7-9 months postnatal

    Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013). 0 (Not At All) to 4 (Most of the Time). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  6. Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)

    Time frame: 12 months postnatal

    Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013). 0 (Not At All) to 4 (Most of the Time). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  7. Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)

    Time frame: Baseline

    Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987). Items 1, 2, & 4: Scored 0 to 3 (0 being "As much as I always could" and 3 being "Not at all"). Items 3, 5-10 (Reverse Scored): Scored 3 to 0 (3 being "Yes, most of the time" or "Yes, quite often", 0 being "No, not at all"). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  8. Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)

    Time frame: 7-9 months postnatal

    Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987). Items 1, 2, & 4: Scored 0 to 3 (0 being "As much as I always could" and 3 being "Not at all"). Items 3, 5-10 (Reverse Scored): Scored 3 to 0 (3 being "Yes, most of the time" or "Yes, quite often", 0 being "No, not at all"). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  9. Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)

    Time frame: 12 months postnatal

    Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987). Items 1, 2, & 4: Scored 0 to 3 (0 being "As much as I always could" and 3 being "Not at all"). Items 3, 5-10 (Reverse Scored): Scored 3 to 0 (3 being "Yes, most of the time" or "Yes, quite often", 0 being "No, not at all"). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  10. Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L)

    Time frame: Baseline

    Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  11. Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L)

    Time frame: 7-9 months postnatal

    Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  12. Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L)

    Time frame: 12 months postnatal

    Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.

  13. Participation Rate

    Time frame: Through study completion, an average of 1.5 years

    The proportion of eligible parents who agreed to participate

  14. Intervention Completion Rate

    Time frame: Through study completion, an average of 1.5 years

    The proportion of participants who completed the counselling intervention

  15. Study Procedure Completion Rate

    Time frame: Through study completion, an average of 1.5 years

    The proportion of participants who completed all of the study procedures

Secondary outcomes

  1. Descriptions of participants' experiences of their involvement in the study

    Time frame: 7-9 months post-loss

    Open-ended questions requiring a written response on the second questionnaire for intervention participants

  2. Descriptions of healthcare professionals' experiences of their involvement in the study

    Time frame: One interview for 50 minutes 1-2 weeks following the end of the trial

    Semi-structured interviews with 4 healthcare professionals involved in the trial

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

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

Acronym: PEARL-C

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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