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Completed

NCT Number: NCT05911204

Exposure to Intense and Prolonged Noises During Pregnancy

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.

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Key information

Conditions

Noise Exposure

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire about intense noises exposure during pregnancy

Other

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

Primary outcomes

  1. 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

  1. Impact of noise exposure during pregnancy on health status, qualitative variable

    Time frame: Collected 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)

  2. Newborn hearing screening, binary variable (presence of hearing impairment, absence of hearing impairment)

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

    Collection of the results of the routine hearing screening of the infants (presence of hearing impairment, absence of hearing impairment)

  3. Women's knowledge of the risk of noise exposure during pregnancy on newborn hearing impairment, binary variable

    Time frame: 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

    a questionnaire given to the mother after the birth (yes or no)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: GestaNoise

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 20, 2023
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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