NCT06340555

Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss

Multiprofessional Healthcare Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss (Enzo Study): A Hybrid Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stillbirth and Fetal Death

Interventions

Type	Name	Description
OTHER	GUIA ATENCION MULTIDISCIPLINAR SANT BOI	Women with losses attended according to the multidisciplinary intervention proposed at the SJD Hospital de Sant Boi
OTHER	USUAL CARE	Women with losses treated at the Hospital Comarcal del l'Alt Penedes.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-12-31
• Completion: 2025-07-31
• First posted: 2024-04-01
• Last updated: 2024-04-01

Locations

1 site across 1 country: Spain