Stillbirth and Fetal DeathEnzoNCT06340555
Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss
A study testing GUIA ATENCION MULTIDISCIPLINAR SANT BOI in people with Stillbirth and Fetal Death, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stillbirth and Fetal Death
- What is being tested?
- GUIA ATENCION MULTIDISCIPLINAR SANT BOI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and their partners who suffer a pregnancy loss
- Health professionals who have worked for at least 1 year in the hospital studied
Who cannot join
- Participants who do not understand spanish/catalan
Trial locations and contacts
1 site in 1 country.
Spain1 site
Parc Sanitari Sant Joan de Deu
Sant Boi de Llobregat, Barcelona, 08830
About this study
Official title: 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.
Read the 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).
- Conditions
- Stillbirth and Fetal Death
- Being tested
- GUIA ATENCION MULTIDISCIPLINAR SANT BOI, USUAL CARE
- Medical subject headings
- Stillbirth, Fetal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUIA ATENCION MULTIDISCIPLINAR SANT BOIOther
Women with losses attended according to the multidisciplinary intervention proposed at the SJD Hospital de Sant Boi
USUAL CAREOther
Women with losses treated at the Hospital Comarcal del l'Alt Penedes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: USUAL CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of grief
Measured with Perinatal Grief Score (PGS Scale)
Measured: 6 months
Secondary outcomes (3)
Depressive symptoms
Measured with Edinburgh Scale
Measured: 6 months
Anxiety symptoms
Measured with Generalized Anxiety Disorder (GAD-7 Scale)
Measured: 6 months
Perinatal postraumatic stress disorder
Measured with Perinatal Postraumatic Questionnaire (PPQ Scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stillbirth and Fetal DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona, University of Seville
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340555
- Sponsor's protocol ID
- PIC-156-22
- Acronym
- Enzo
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiprofessional Healthcare Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss (Enzo Study): A Hybrid Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06340555
- Acronym / sponsor ID
- Enzo / PIC-156-22
- Conditions
- Stillbirth and Fetal Death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- University of Barcelona, University of Seville
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzo intervencion group | Experimental | Other: GUIA ATENCION MULTIDISCIPLINAR SANT BOIThe 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 | Active comparator | Other: USUAL CAREIt is the usual care intervention which consists in: diagnosis given by the doctor, intrapartum routine care and follow up on discharge by gynaecologist team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women and their partners who suffer a pregnancy loss
- Health professionals who have worked for at least 1 year in the hospital studied
Key exclusion criteria (1 listed)
- Participants who do not understand spanish/catalan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GUIA ATENCION MULTIDISCIPLINAR SANT BOIWomen with losses attended according to the multidisciplinary intervention proposed at the SJD Hospital de Sant Boi | Other | Enzo intervencion group |
| USUAL CAREWomen with losses treated at the Hospital Comarcal del l'Alt Penedes. | Other | Control group |
Primary outcome
Intensity of grief
Time frame: 6 months
Measured with Perinatal Grief Score (PGS Scale)
3 secondary outcomes
Depressive symptoms
Time frame: 6 months
Anxiety symptoms
Time frame: 6 months
Perinatal postraumatic stress disorder
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GUIA ATENCION MULTIDISCIPLINAR SANT BOI in people with Stillbirth and Fetal Death, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of grief (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.