Multiprofessional Healthcare Intervention to Prevent Mental Health Disorders of Women and Their Partners Who Experienced Pregnancy Loss (Enzo Study): A Hybrid Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intensity of grief
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and their partners who suffer a pregnancy loss
- •Health professionals who have worked for at least 1 year in the hospital studied
排除标准
- •Participants who do not understand spanish/catalan
研究组 & 干预措施
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.
干预措施: GUIA ATENCION MULTIDISCIPLINAR SANT BOI (Other)
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.
干预措施: USUAL CARE (Other)
结局指标
主要结局
Intensity of grief
时间窗: 6 months
Measured with Perinatal Grief Score (PGS Scale)
次要结局
- Depressive symptoms(6 months)
- Anxiety symptoms(6 months)
- Perinatal postraumatic stress disorder(6 months)