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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stillbirth and Fetal Death
• Intervention / Treatment: Other: GUIA ATENCION MULTIDISCIPLINAR SANT BOI; Other: USUAL CARE

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sant Boi De Llobregat, Barcelona, Spain, 08830
      • Parc Sanitari Sant Joan de Déu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enzo intervencion group; The hospital 1 guide for care consists on a multidisciplinary team intervention on three moments related to the loss: diagnose, intrapartum, postpartum.; Diagnose: we aim to inform, prepare following procedures and support in the decision-making.; Intrapartum: we aim to reduce or even avoid trauma caused by the situation.; 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; Women with losses attended according to the multidisciplinary intervention proposed at the SJD Hospital de Sant Boi
Active Comparator: Control group; 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; Women with losses treated at the Hospital Comarcal del l'Alt Penedes.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Collaborators: University of Seville; University of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Fetal Death; Stillbirth
• Other Study ID Numbers: PIC-156-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No