Multiprofessional Healthcare Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss (Enzo Study): A Hybrid Controlled Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stillbirth and Fetal Death
- Sponsor
- Fundació Sant Joan de Déu
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Intensity of grief
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to test impact of a multiprofessional intervention in mothers and partners who suffer a pregnancy loss. The main questions it aims to answer are:
- impact on mothers and partners mental heatlht status
- reasons why mothers do not consent to the intervention
Participants will:
- mothers and partners will complete 4 scales
- mothers and partners will participate in a interview
Researchers will compare with mothers with standard care to see if the multiprofessional intervention has an impact.
Detailed Description
Objective 1: Evaluate the effectiveness of the multi professional intervention to reduce the intensity of grief, depression, anxiety and PTSD symptoms in women and their partners after pregnancy loss. Objective 2: Assess the extent to which the multiprofessional intervention was implemented as intended (fidelity) and understand how the intervention becomes integrated into routine healthcare practice (implementation).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women and their partners who suffer a pregnancy loss
- •Health professionals who have worked for at least 1 year in the hospital studied
Exclusion Criteria
- •Participants who do not understand spanish/catalan
Outcomes
Primary Outcomes
Intensity of grief
Time Frame: 6 months
Measured with Perinatal Grief Score (PGS Scale)
Secondary Outcomes
- Depressive symptoms(6 months)
- Anxiety symptoms(6 months)
- Perinatal postraumatic stress disorder(6 months)