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临床试验/NCT05911204
NCT05911204已完成不适用

Prevalence of Women Exposed to Intense and Prolonged Noises During the 3rd Trimester of Pregnancy

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Exposure to Intense and Prolonged Noises during Pregnancy

研究概览

简要总结

Hearing is an essential element for the development of language and conditions an appropriate cognitive, psychological and social development of children. Therefore, congenital deafness represents a real public health problem, justifying the implementation of a national neonatal screening for hearing disorders in newborns.

The intensity at which the fetus perceives sound at 27-29 weeks of amenorrhea (SA) is about 40 decibels (dB), it recognizes its mother's voice from the 33rd SA, and then its perception capacity evolves to the adult level at term. These data suggest that the fetus is sensitive to its sound environment from the 3rd trimester of pregnancy. The development of hearing could be damaged in case of prolonged exposure to intense noise. Studies have demonstrated an harmful effects of long and sustained exposure to noise on hearing in adults. In addition, a recent survey showed that 40% of the population of Ile-de-France felt that noise had a significant impact on their health . The effects of prolonged loud noise exposure on human fetal hearing are not fully understood and few studies have assessed the prevalence of women exposed to loud and lengthy noise in a population of postpartum women. This study aims evaluating the prevalence and the impacte of an exposure to Intense and Prolonged Noises during Pregnancy.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Woman who gave birth at the Nancy Regional Maternity Hospital
  • Woman having received complete information on the organization of the research and not having objected to her participation and the use of her data
  • Woman affiliated to a social security scheme or beneficiary of such a scheme
  • Woman understanding French and able to complete a self-questionnaire or having the possibility of being assisted for the filling

排除标准

  • Woman for whom a diagnosis of malformation or genetic anomaly of the fetus was established in the antenatal period

结局指标

主要结局

Exposure to Intense and Prolonged Noises during Pregnancy

时间窗: Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery

A questionnaire will be given to the mother within 3 days after delivery

次要结局

  • Impact of noise exposure during pregnancy on health status, qualitative variable(Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery,)
  • Women's knowledge of the risk of noise exposure during pregnancy on newborn hearing impairment, binary variable(Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery, where existing data on newborn hearing screening will be collected)
  • Newborn hearing screening, binary variable (presence of hearing impairment, absence of hearing impairment)(Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Michel HASCOET

Professor

Central Hospital, Nancy, France

研究点 (1)

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