Exposure to Intense and Prolonged Noises During Pregnancy

NCT ID: NCT05911204

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-03

Study Completion Date

2024-06-21

Brief Summary

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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.

Detailed Description

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Conditions

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Noise Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mothers

One single group of mothers exposed to intense and sustained noises during pregnancy

Questionnaire about intense noises exposure during pregnancy

Intervention Type OTHER

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

Interventions

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Questionnaire about intense noises exposure during pregnancy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Jean-Michel HASCOET

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, France

Site Status

Countries

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France

Other Identifiers

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2023-A00588-37

Identifier Type: -

Identifier Source: org_study_id

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