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

Not Applicable

Active, not recruiting

• Conditions: Stillbirth and Fetal Death
• Interventions: Other: GUIA ATENCION MULTIDISCIPLINAR SANT BOI; Other: USUAL CARE

• Registration Number: NCT06340555
• Lead Sponsor: Fundació Sant Joan de Déu

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).

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enzo intervencion group	GUIA ATENCION MULTIDISCIPLINAR SANT BOI	The hospital 1 guide for care consists on a multidisciplinary team intervention on three moments related to the loss: diagnose, intrapartum, postpartum. 1. Diagnose: we aim to inform, prepare following procedures and support in the decision-making. 2. Intrapartum: we aim to reduce or even avoid trauma caused by the situation. 3. Postpartum: we aim to ensure mother and partner are able to say good-bye absolutely how they planned and/or desire at each time. Also, coordinate continuum of care after hospital discharge.
Control group	USUAL CARE	It is the usual care intervention which consists in: diagnosis given by the doctor, intrapartum routine care and follow up on discharge by gynaecologist team.

Primary Outcome Measures

Name	Time	Method
Intensity of grief	6 months	Measured with Perinatal Grief Score (PGS Scale)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Parc Sanitari Sant Joan de Deu; 🇪🇸 Sant Boi De Llobregat, Barcelona, Spain