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

NCT07494760 | Not Yet Recruiting

• 1 other identifier: 348762
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stillbirth; Perinatal Death; Psychological; Grief

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (2)

• Descriptions of participants' experiences of their involvement in the study

  7-9 months post-loss

• Descriptions of healthcare professionals' experiences of their involvement in the study

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

Study Arms (2)

Bereavement Counselling

EXPERIMENTAL

Bereavement counselling from a specialist bereavement counsellor

Other: Bereavement Counselling; Other: Usual bereavement care

Usual bereavement care

ACTIVE COMPARATOR

Routine care provided by the bereavement team

Other: Usual bereavement care

Interventions

Bereavement Counselling OTHER

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

Bereavement Counselling

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

Bereavement Counselling; Usual bereavement care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Manchester: lead

MeSH Terms

Conditions

Stillbirth; Perinatal Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03