Exposure to Intense and Prolonged Noises During Pregnancy (GestaNoise)

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

Study Overview

• Status: Completed
• Conditions: Noise Exposure
• Intervention / Treatment: Other: Questionnaire about intense noises exposure during pregnancy

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54035
      • Maternite Regionale Universitaire CHRU NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mothers; One single group of mothers exposed to intense and sustained noises during pregnancy	Other: Questionnaire about intense noises exposure during pregnancy; Response to questionnaire given within 3 days after delivery about noise exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,
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
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 20, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pregnancy; Intense and prolonged noise
• Other Study ID Numbers: 2023-A00588-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No