A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experienced a Perinatal Death (PEARL-C)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perinatal Death; Grief; Psychological; Stillbirth
• Intervention / Treatment: Other: Bereavement Counselling; Other: Usual bereavement care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bereavement Counselling; Bereavement counselling from a specialist bereavement counsellor	Other: Bereavement Counselling; Bereavement counselling for 6-8 sessions over a 3-month period beginning 3-4 months after a perinatal death; Other: Usual bereavement care; 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
Active Comparator: Usual bereavement care; Routine care provided by the bereavement team	Other: Usual bereavement care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)	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.	Baseline
Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)	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.	7-9 months postnatal
Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)	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.	12 months postnatal
Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)	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.	Baseline
Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)	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.	7-9 months postnatal
Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)	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.	12 months postnatal
Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)	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.	Baseline
Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)	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.	7-9 months postnatal
Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987)	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.	12 months postnatal
Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L)	Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.	Baseline
Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L)	Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.	7-9 months postnatal
Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L)	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 months postnatal
Participation Rate	The proportion of eligible parents who agreed to participate	Through study completion, an average of 1.5 years
Intervention Completion Rate	The proportion of participants who completed the counselling intervention	Through study completion, an average of 1.5 years
Study Procedure Completion Rate	The proportion of participants who completed all of the study procedures	Through study completion, an average of 1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptions of participants' experiences of their involvement in the study	Open-ended questions requiring a written response on the second questionnaire for intervention participants	7-9 months post-loss
Descriptions of healthcare professionals' experiences of their involvement in the study	Semi-structured interviews with 4 healthcare professionals involved in the trial	One interview for 50 minutes 1-2 weeks following the end of the trial

Collaborators and Investigators

• Sponsor: University of Manchester

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Fetal Death; Pathological Conditions, Signs and Symptoms; Stillbirth; Perinatal Death
• Other Study ID Numbers: 348762

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No