Pilot-testing a Perinatal Palliative Care Intervention Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-18

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mobilized Psychoeducation and Skills Based Intervention (Pep-Pal) for Caregivers of Patients With Advanced Illness

NCT03002896

Distress Anxiety Depression

COMPLETED NA

Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline

NCT07343258

Suicide Suicidal Ideation and Behavior Crisis Intervention

RECRUITING NA

A Hypnosis-based Group Intervention to Improve Quality of Life in Children With Cancer and Their Parents.

NCT03435042

Pediatric Cancer

RECRUITING NA

Intimate Partner Violence and Pregnancy, a Perinatal Care Intervention Study

NCT01158690

Intimate Partner Violence

COMPLETED NA

Online Mind/Body Program for Fertility

NCT03343405

Infertility

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perinatal Palliative Care Life-limiting Fetal Diagnosis Life-limiting Neonatal Diagnosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Baseline group

Receives care as usual after severe perinatal diagnosis

Group Type NO_INTERVENTION

No interventions assigned to this group

Perinatal palliative care group

Receives a new perinatal palliative care intervention after severe perinatal diagnosis

Group Type EXPERIMENTAL

Perinatal palliative care

Intervention Type BEHAVIORAL

Intervention group will receive specialized perinatal palliative care support from moment of severe perinatal diagnosis. This intervention is aimed at 5 major care components, namely 1. Support offered by a fixed perinatal palliative care team, 2. that team has received specialized perinatal palliative care training, 3. care is structured within a new perinatal palliative care approach or pathway, including fixed means of communication with team members, 4. psychological support is structurally being offered to parents and healthcare providers, and 5. debriefings after every perinatal death are being organized in the involved team.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Perinatal palliative care

Intervention group will receive specialized perinatal palliative care support from moment of severe perinatal diagnosis. This intervention is aimed at 5 major care components, namely 1. Support offered by a fixed perinatal palliative care team, 2. that team has received specialized perinatal palliative care training, 3. care is structured within a new perinatal palliative care approach or pathway, including fixed means of communication with team members, 4. psychological support is structurally being offered to parents and healthcare providers, and 5. debriefings after every perinatal death are being organized in the involved team.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Parents:

* who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or
* who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child
* Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth

* Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "Agentschap Integratie \& Inburgering"
* Parents are older than 18
* Parents are not suffering from an officially diagnosed psychiatric disorder prior to receiving the severe diagnosis of their child
* Parents are deemed (emotionally) approachable for the current study by the treating physician

For each family included in the pilot study, the physicians and nurses/midwives who will be/are most closely involved in the care of the infant and the parents will also be asked to participate. If healthcare providers refuse to provide informed consent to participate in the study, their data will be deemed as missing for that case (parental outcomes are considered as the primary outcome measures).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No