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临床试验/NCT04658810
NCT04658810已完成不适用

Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy, Without Ultrasound Signs or With Non-serious Ultrasound Signs of Maternal-fetal CMV Infection.

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2021年5月2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
87
试验地点
2
主要终点
PTSD evaluation

研究概览

简要总结

Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection.

The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers

研究设计

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

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

  • Referred to the 3 DAN centers with maternal seroconversion to CMV during their pregnancy, confirmed, with or without confirmed prenatal transmission.
  • Presence of ultrasound signs without criteria of seriousness if the materno-fetal infection is proven.
  • Support between January 1, 2008 and December 31,
  • No opposition from patient

排除标准

  • Reversed or anteconceptional CMV seroconversion
  • Concomitant infection with another infectious agent and suspected cross-reaction
  • Multiple pregnancy
  • Ultrasound and / or MRI severity criteria
  • Medical termination of pregnancy
  • Fetal death in utero
  • Birth <32 weeks and / or birth weight <1500 grams (birth criteria in maternity level IIA)
  • Intercurrent event that may be the cause of an abnormality in psychomotor development
  • Patients protected by justice

结局指标

主要结局

PTSD evaluation

时间窗: Through study completion, 3 months

Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder scale (PPQ questionnaire)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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