Skip to main content
Clinical Trials/NCT05911204
NCT05911204CompletedNot Applicable

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

Central Hospital, Nancy, France1 site in 1 country1,000 target enrollmentStarted: July 3, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,000
Locations
1
Primary Endpoint
Exposure to Intense and Prolonged Noises during Pregnancy

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Exposure to Intense and Prolonged Noises during Pregnancy

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jean-Michel HASCOET

Professor

Central Hospital, Nancy, France

Study Sites (1)

Loading locations...

Similar Trials