Exposure to Intense and Prolonged Noises During Pregnancy

NCT05911204 | Completed

• 1 other identifier: 2023-A00588-37
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Noise Exposure

Keywords

Pregnancy; Intense and prolonged noise

Outcome Measures

Primary Outcomes (1)

• Exposure to Intense and Prolonged Noises during Pregnancy

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

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

Secondary Outcomes (3)

• 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,

• 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

• 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

Study Arms (1)

Mothers

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

Other: Questionnaire about intense noises exposure during pregnancy

Interventions

Questionnaire about intense noises exposure during pregnancy OTHER

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

Mothers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All mothers above 18 years old who have given birth and are cared for at the Nancy Regional University Maternity will be offered a questionnaire upon their arrival in their room in the mother-child sector

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 20, 2023
• Study Start: July 3, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 21, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

FR (1)