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

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06340555

Acronym

Enzo

Enrollment

120

Registered

2024-04-01

Start date

2024-03-01

Completion date

2025-07-31

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stillbirth and Fetal Death

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).

Interventions

OTHERGUIA ATENCION MULTIDISCIPLINAR SANT BOI

Women with losses attended according to the multidisciplinary intervention proposed at the SJD Hospital de Sant Boi

OTHERUSUAL CARE

Women with losses treated at the Hospital Comarcal del l'Alt Penedes.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intensity of grief	6 months	Measured with Perinatal Grief Score (PGS Scale)

Secondary

Measure	Time frame	Description
Depressive symptoms	6 months	Measured with Edinburgh Scale
Anxiety symptoms	6 months	Measured with Generalized Anxiety Disorder (GAD-7 Scale)
Perinatal postraumatic stress disorder	6 months	Measured with Perinatal Postraumatic Questionnaire (PPQ Scale)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026