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

Stillbirth and Fetal Death Clinical Trial

— Enzo  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06340555
• Other study ID #: PIC-156-22
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Death
• Mental Disorders
• Stillbirth
• Stillbirth and Fetal Death

Intervention

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

Locations

Country	Name	City	State
Spain	Parc Sanitari Sant Joan de Deu	Sant Boi De Llobregat	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	University of Barcelona, University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of grief	Measured with Perinatal Grief Score (PGS Scale)	6 months
Secondary	Depressive symptoms	Measured with Edinburgh Scale	6 months
Secondary	Anxiety symptoms	Measured with Generalized Anxiety Disorder (GAD-7 Scale)	6 months
Secondary	Perinatal postraumatic stress disorder	Measured with Perinatal Postraumatic Questionnaire (PPQ Scale)	6 months