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

NCT06340555 | Active Not Recruiting

• 1 other identifier: PIC-156-22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stillbirth and Fetal Death

Outcome Measures

Primary Outcomes (1)

• Intensity of grief

  Measured with Perinatal Grief Score (PGS Scale)

  6 months

Secondary Outcomes (3)

• Depressive symptoms

  6 months

• Anxiety symptoms

  6 months

• Perinatal postraumatic stress disorder

  6 months

Study Arms (2)

Enzo intervencion group

EXPERIMENTAL

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.

Other: GUIA ATENCION MULTIDISCIPLINAR SANT BOI

Control group

ACTIVE COMPARATOR

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.

Other: USUAL CARE

Interventions

GUIA ATENCION MULTIDISCIPLINAR SANT BOI OTHER

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

Enzo intervencion group

USUAL CARE OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and their partners who suffer a pregnancy loss
• Health professionals who have worked for at least 1 year in the hospital studied

You may not qualify if:

• Participants who do not understand spanish/catalan

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• University of Barcelona: collaborator
• University of Seville: collaborator

Study Sites (1)

Parc Sanitari Sant Joan de Deu

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

MeSH Terms

Conditions

Stillbirth; Fetal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

ES (1)