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临床试验/NCT06664593
NCT06664593已完成不适用

Detection of Perinatal Mental Disorders

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
378
试验地点
1
主要终点
association of psychosocial and obstetric risk factors with perinatal anxiety and depression

研究概览

简要总结

Having a baby is a major life event, and for some women, it can increase the risk of developing mental health issues. A recent survey in the UK found that one in five women experience mental health problems during pregnancy or after giving birth. Unfortunately, many of these problems go unnoticed without regular check-ups, and only one in ten women receive the support they need. Regular mental health screenings can help detect these problems early, ensuring women receive the right care and support.

The study at UZ Gent aims to improve how depression and anxiety are detected in pregnant and postpartum women by using a perinatal screening protocol. This protocol involves screening women for psychosocial risks around the 16th week of pregnancy, which is done by a midwife. Further screenings take place during the second trimester (around 20 weeks) and again six weeks after birth, using questionnaires to assess for depression and anxiety (Whooley, EPDS, GAD-2, GAD-7).

If the assessment of risk factors or the screening for depression and anxiety is positive, further assessment and treatment are offered at the women's clinic. A positive screening may lead to a recommendation for a diagnostic interview, such as a semi-structured interview (M.I.N.I.), with a psychiatrist, general practitioner, or psychologist to assess for possible depression or anxiety disorders. If needed, appropriate treatment will be provided.

The study will explore how common depression and anxiety are during and after pregnancy, what factors increase the risk, and whether the screening process improves early detection and treatment. The ultimate goal is to help more women get the mental health support they need during this critical time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged ≥ 18 years, receiving regular care follow-up in a university hospital

排除标准

  • Non-Dutch speakers were excluded. Additionally, no data were collected from women in the vulnerable care pathway, which provides psychosocial support to those facing barriers in employment, income, housing, education, and healthcare. This group includes teenage mothers (under 18), women with intellectual disabilities, new immigrants, refugees, homeless women, and those with severe psychiatric or addiction issues referred by their psychiatrist or GP.

结局指标

主要结局

association of psychosocial and obstetric risk factors with perinatal anxiety and depression

时间窗: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum

Using a semi-structured interview, the midwife assesses psychosocial risk factors identified from a literature review. Key factors include financial and housing problems, unplanned or unwanted pregnancy, lack of social support, experiences of violence (physical, sexual, or emotional), personal and family psychiatric history, and substance use. Screening for depressive and anxiety symptoms followed a stepped protocol. All participants answered Yes/No to the Whooley questions (depression) and GAD-2 (anxiety). If a participant answered positively to at least one Whooley question or both GAD-2 questions, the Edinburgh Depression Scale (EDS) was administered. A score of 13 or higher on the EDS indicated a positive depression screen. If participants scored 5 or higher on the EDS-3A (anxiety subscale), the GAD-7 was administered, with a score of 15 or higher indicating a positive anxiety screen. Obstetric information was collected from the electronic patient medical records.

association between the number of (significant) risk factors and depressive and anxiety symptoms using a cumulative risk index

时间窗: from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum

次要结局

  • prevalence of depressive and anxiety symptoms(from enrollment at 16 weeks of pregnancy to follow-up consult at 6-8 weeks postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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