GestaNoise: Exposure to Intense and Prolonged Noises During Pregnancy

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05911204
Collaborator
(none)
1,500
1
11
136.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire about intense noises exposure during pregnancy

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence of Women Exposed to Intense and Prolonged Noises During the 3rd Trimester of Pregnancy
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Exposure to Intense and Prolonged Noises during Pregnancy [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 Outcome Measures

  1. 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,]

    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) [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maternite Regionale Universitaire CHRU NANCY Nancy Lorraine France 54035

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jean-Michel HASCOET, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05911204
Other Study ID Numbers:
  • 2023-A00588-37
First Posted:
Jun 20, 2023
Last Update Posted:
Jun 20, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jean-Michel HASCOET, Professor, Central Hospital, Nancy, France

Study Results

No Results Posted as of Jun 20, 2023