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Exposure to Intense and Prolonged Noises During Pregnancy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05911204
Acronym
GestaNoise
Enrollment
1000
Registered
2023-06-20
Start date
2023-07-03
Completion date
2024-06-21
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noise Exposure

Keywords

Pregnancy, Intense and prolonged noise

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.

Interventions

OTHERQuestionnaire about intense noises exposure during pregnancy

Response to questionnaire given within 3 days after delivery about noise exposure

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Exposure to Intense and Prolonged Noises during PregnancyCollected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of deliveryA questionnaire will be given to the mother within 3 days after delivery

Secondary

MeasureTime frameDescription
Impact of noise exposure during pregnancy on health status, qualitative variableCollected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery,A questionnaire given to the mother collecting her feelings on the impact of noise (no; some; heavy)
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 deliveryCollection of the results of the routine hearing screening of the infants (presence of hearing impairment, absence of hearing impairment)
Women's knowledge of the risk of noise exposure during pregnancy on newborn hearing impairment, binary variableCollected 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 collecteda questionnaire given to the mother after the birth (yes or no)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026