Clinical trial NCT05911204: Exposure to Intense and Prolonged Noises During Pregnancy
Official title: Prevalence of Women Exposed to Intense and Prolonged Noises During the 3rd Trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noise Exposure
Keywords: Pregnancy
Intense and prolonged noise
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Exposure to Intense and Prolonged Noises during Pregnancy
timeFrame: Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery
Secondary outcomes:
measure: Impact of noise exposure during pregnancy on health status, qualitative variable
timeFrame: Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery,
measure: Newborn hearing screening, binary variable (presence of hearing impairment, absence of hearing impairment)
timeFrame: Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery
measure: Women's knowledge of the risk of noise exposure during pregnancy on newborn hearing impairment, binary variable
timeFrame: 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
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale Universitaire CHRU NANCY
state: Lorraine
Study officials:
References: