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

Fundació Sant Joan de Déu

Status: Active, not recruiting

Conditions: Stillbirth and Fetal Death

Treatments: Other: GUIA ATENCION MULTIDISCIPLINAR SANT BOI; Other: USUAL CARE

Study type: Interventional

Funder types: Other

Identifiers

NCT06340555

PIC-156-22

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Enzo intervencion group

Experimental group

Description:

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.

Treatment:

Other: GUIA ATENCION MULTIDISCIPLINAR SANT BOI

Control group

Active Comparator group

Description:

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.

Treatment:

Other: USUAL CARE