Noise ExposureGestaNoiseNCT05911204
Exposure to Intense and Prolonged Noises During Pregnancy
An observational study of Noise Exposure, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure
- What is being tested?
- Questionnaire about intense noises exposure during pregnancy
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2023to 21 Jun 2024
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- Woman for whom a diagnosis of malformation or genetic anomaly of the fetus was established in the antenatal period
Trial locations and contacts
1 site in 1 country.
France1 site
Maternite Regionale Universitaire CHRU NANCY
Nancy, Lorraine, 54035
About this study
Official title: 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.
- Conditions
- Noise Exposure
- Being tested
- Questionnaire about intense noises exposure during pregnancy
- Keywords
- Pregnancy, Intense and prolonged noise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about intense noises exposure during pregnancyOther
Response to questionnaire given within 3 days after delivery about noise exposure
| Study group | Role | What they receive |
|---|---|---|
| Mothers | One single group of mothers exposed to intense and sustained noises during pregnancy Receives: Other: Questionnaire about intense noises exposure during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to Intense and Prolonged Noises during Pregnancy
A questionnaire will be given to the mother within 3 days after delivery
Measured: 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
A questionnaire given to the mother collecting her feelings on the impact of noise (no; some; heavy)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start3 Jul 2023
- Primary completion1 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911204
- Sponsor's protocol ID
- 2023-A00588-37
- Acronym
- GestaNoise
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Women Exposed to Intense and Prolonged Noises During the 3rd Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT05911204
- Acronym / sponsor ID
- GestaNoise / 2023-A00588-37
- Conditions
- Noise Exposure
- Keywords
- Pregnancy, Intense and prolonged noise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mothers | – | Other: Questionnaire about intense noises exposure during pregnancyOne single group of mothers exposed to intense and sustained noises during pregnancy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Woman for whom a diagnosis of malformation or genetic anomaly of the fetus was established in the antenatal period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire about intense noises exposure during pregnancyResponse to questionnaire given within 3 days after delivery about noise exposure | Other | Mothers |
Primary outcome
Exposure to Intense and Prolonged Noises during Pregnancy
Time frame: 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
3 secondary outcomes
Impact of noise exposure during pregnancy on health status, qualitative variable
Time frame: 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)
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
Related trials for Noise Exposure
Active, not recruitingObservational study
Federal Aviation Administration (FAA) National Sleep Study
Noise Exposure
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
RecruitingObservational study
Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia
General Anesthesia, Hemodynamics
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noise Exposure, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exposure to Intense and Prolonged Noises during Pregnancy (time frame: Collected at the routine newborn discharge examination, 72 or 96 hours after delivery, depending on the type of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.