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临床试验/NCT04377412
NCT04377412Unknown不适用

Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

Żelazna Medical Centre, LLC17 个研究点 分布在 15 个国家目标入组 8,500 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
8,500
试验地点
17
主要终点
Anxiety

研究概览

简要总结

The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

  • declaration of being pregnant
  • being able to complete the survey in the available languages
  • answer the screening questions
  • provide informed consent for participation

排除标准

  • not providing online informed consent for participation
  • if the participant does not click on the submit button at the end of the survey
  • not answer all the GAD-7 and PHQ-9 scale questions

结局指标

主要结局

Anxiety

时间窗: 4 months

Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; \>15 severe. Minimum 0, maximum 21 points

Depression

时间窗: 4 months

Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; \>20 severe. Minimum 0 maximum 27 points

次要结局

未报告次要终点

研究者

发起方
Żelazna Medical Centre, LLC
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Kajdy

Md, PhD

Centre of Postgraduate Medical Education

研究点 (17)

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