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临床试验/NCT07827508
NCT07827508尚未招募不适用

Assessment of Childbirth-Related Post-Traumatic Stress Disorder: A Single-Center Prospective Study

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
City Birth Trauma Scale

研究概览

简要总结

The main objective of this study is to estimate the prevalence of childbirth-related post-traumatic stress disorder (PTSD) among mothers treated at the maternity ward of Emile Muller Hospital (Mulhouse, Haut-Rhin, France).

详细描述

Secondary objectives

  1. To identify risk factors associated with the development of PTSD, in order to determine which situations-particularly obstetric ones-could lead women to experience trauma, and understand the underlying psychological mechanisms.

Risk factors identified in the literature or deemed relevant by the study's clinicians and psychologists will be gathered from medical records. 2. To assess healthcare utilization in the context of the onset of childbirth-related PTSD from the women's perspective, using a questionnaire consisting of a series of questions about the different healthcare professionals consulted during the month following childbirth.

Conduct of research About one month after giving birth, women who have provided their consent will receive an email containing a personal link to the eCRF page where they will find the French version of the "City Birth Trauma Scale" (CBTS) questionnaire, as well as the questionnaire designed to assess their use of healthcare services.

After completing the CBTS questionnaire, the participant can choose to check a box in the eCRF to indicate whether or not she wishes to be contacted by the research team in the event that her score suggests a diagnosis of PTSD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Women aged 18 or older
  • Having given birth in the maternity ward at Emile Muller Hospital (Mulhouse, Haut-Rhin, France)
  • Fluent in French
  • Having provided written consent to participate in the study
  • Being covered by a social security program

排除标准

  • Women who gave birth anonymously
  • Women who gave birth to a stillborn child or a fetus that died in utero
  • Women under legal protection (guardianship, conservatorship, judicial protection).

研究组 & 干预措施

Women who have given birth within the past month

Other

干预措施: City Birth Trauma Scale and Questionnaire on the assessment of healthcare utilization (Diagnostic Test)

结局指标

主要结局

City Birth Trauma Scale

时间窗: About 1 month after childbirth

The diagnosis of PTSD based on responses to the questionnaire will be made in accordance with the questionnaire's scoring method, which assesses 8 criteria based on the DSM-5 (criteria labeled A through H).

次要结局

  • Questionnaire on the assessment of healthcare utilization(About 1 month after childbirth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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