Exposure to Intense and Prolonged Noises During Pregnancy

Noise Exposure Clinical Trial

— GestaNoise  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911204
• Other study ID #: 2023-A00588-37
• Status: Recruiting
• Start date: July 3, 2023
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: Jean-Michel HASCOET, MD
• Phone: +33 383 342 934
• Email: j.hascoet[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Noise Exposure

Intervention

Other:
• Questionnaire about intense noises exposure during pregnancy
Response to questionnaire given within 3 days after delivery about noise exposure

Locations

Country	Name	City	State
France	Maternite Regionale Universitaire CHRU NANCY	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of noise exposure during pregnancy on health status, qualitative variable	A questionnaire given to the mother collecting her feelings on the impact of noise (no; some; heavy)	Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery,
Secondary	Newborn hearing screening, binary variable (presence of hearing impairment, absence of hearing impairment)	Collection of the results of the routine hearing screening of the infants (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
Secondary	Women's knowledge of the risk of noise exposure during pregnancy on newborn hearing impairment, binary variable	a questionnaire given to the mother after the birth (yes or no)	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