StillbirthPEARL-CNCT07494760
A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experienced a Perinatal Death
A study testing Bereavement Counselling and Usual bereavement care in people with Stillbirth and Perinatal Death, run by University of Manchester.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stillbirth, Perinatal Death, Psychological
- What is being tested?
- Bereavement Counselling and Usual bereavement care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Stillbirth, Perinatal Death, Psychological, Grief
- Being tested
- Bereavement Counselling, Usual bereavement care
- Medical subject headings
- Stillbirth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bereavement CounsellingOther
Bereavement counselling for 6-8 sessions over a 3-month period beginning 3-4 months after a perinatal death
Usual bereavement careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Bereavement Counselling | Experimental | Bereavement counselling from a specialist bereavement counsellor Receives: Other: Bereavement Counselling; Other: Usual bereavement care |
| Usual bereavement care | Active comparator | Routine care provided by the bereavement team Receives: Other: Usual bereavement care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months postnatal
Participation Rate
The proportion of eligible parents who agreed to participate
Measured: Through study completion, an average of 1.5 years
Intervention Completion Rate
The proportion of participants who completed the counselling intervention
Measured: Through study completion, an average of 1.5 years
Study Procedure Completion Rate
The proportion of participants who completed all of the study procedures
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (2)
Descriptions of participants' experiences of their involvement in the study
Open-ended questions requiring a written response on the second questionnaire for intervention participants
Measured: 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
Measured: One interview for 50 minutes 1-2 weeks following the end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StillbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Alexander Heazell, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494760
- Sponsor's protocol ID
- 348762
- Acronym
- PEARL-C
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Loss - Early Referral for Counselling (PEARL-C): A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07494760
- Acronym / sponsor ID
- PEARL-C / 348762
- Conditions
- Stillbirth, Perinatal Death, Psychological, Grief
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bereavement Counselling | Experimental | Other: Bereavement Counselling, Other: Usual bereavement careBereavement counselling from a specialist bereavement counsellor |
| Usual bereavement care | Active comparator | Other: Usual bereavement careRoutine care provided by the bereavement team |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bereavement CounsellingBereavement counselling for 6-8 sessions over a 3-month period beginning 3-4 months after a perinatal death | Other | Bereavement Counselling |
| Usual bereavement careRoutine 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 | Other | Bereavement Counselling, Usual bereavement care |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Participation Rate
Time frame: Through study completion, an average of 1.5 years
The proportion of eligible parents who agreed to participate
Intervention Completion Rate
Time frame: Through study completion, an average of 1.5 years
The proportion of participants who completed the counselling intervention
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
2 secondary outcomes
Descriptions of participants' experiences of their involvement in the study
Time frame: 7-9 months post-loss
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Related trials for Stillbirth
RecruitingObservational study
Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
GDM, Preterm Preeclampsia
Not yet recruiting
Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy
Maternal Health, Neonatal Health
RecruitingObservational study
Feasibility Trial of the Womb Watch Smartphone App To Assess Fetal Movements
Assessment of Fetal Movement, Pregnancy
RecruitingPhase 4
Comparison of High- Versus Low-Dose Aspirin for Pregnancy Outcomes in Women at High Risk of Preeclampsia
Preeclampsia
Enrolling by invitation
Pregnancy in the Context of Urbanicity and Climate Change. The Overall Aim of the Project is to Co-create, Implement, and Test New Clinical Guidelines in Order to Improve the Quality of Care in Antenatal Clinics in the Context of Urbanisation and Climate Change in Dar es Salaam, Tanzania.
Perinatal Death, Hypertension, Pregnancy-Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bereavement Counselling and Usual bereavement care in people with Stillbirth and Perinatal Death, run by University of Manchester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988) (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.