PregnancyNCT03233984
Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition
A study testing sensibilisation program "Ma maison, mon environnement santé" in people with Pregnancy and Endocrine System, run by Poitiers University Hospital at 1 site in France.
Trial summary
Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major foetal pathology and impact growth. Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and water. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Endocrine System, Prevention Program
- What is being tested?
- sensibilisation program "Ma maison, mon environnement santé"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2017to 28 Sep 2020
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18
- Patients living in Poitiers or city around (near the immersive environment)
- Patients on pregnancy and who declared their pregnancy to the authority
- Patients who planned to give birth in Poitiers's hospital, Châtellerault's hospital or Clinique Fief de Grimoire, in Poitiers.
- Patients giving her agreement
Who cannot join
- Patients planning to move during the study
- Patients under legal protection
- Patients expecting twins
- Patients unable to speak french
- Patients willing to give birth in another hospital than those mentionned before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention
Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major foetal pathology and impact growth.
Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and water.
Through a prevention program, the investigators tried to warned pregnant women on endocrine disruptors exposition risks. The goal here is to assess the effectiveness of this program on their fresh products consumption.
- Conditions
- Pregnancy, Endocrine System, Prevention Program
- Being tested
- sensibilisation program "Ma maison, mon environnement santé"
- Keywords
- bisphenol-A, prevention, endocrine disruptors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensibilisation program "Ma maison, mon environnement santé"Behavioural
The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.
| Study group | Role | What they receive |
|---|---|---|
| Leaflet only | No intervention | Women will only receive a leaflet about endocrine disruptor at home. |
| non immersive program | Active comparator | In addition of the leaflet, women will sit in the sensibilisation program that will take place in a neutral environment Receives: Behavioral: sensibilisation program "Ma maison, mon environnement santé" |
| immersive program | Experimental | In addition of the leaflet, women will si in the sensibilisation program that will take place in an immersive environment Receives: Behavioral: sensibilisation program "Ma maison, mon environnement santé" |
What is being measured
The primary outcome is the main question the study is designed to answer.
program effectivness
Assessing the Effectiveness of the Prevention Program "My Home, My Health Environment" (consists of a series of workshop in the second and third trimesters of pregnancy) in an immersive environment or not, to evaluate the consumption of fresh products according to exposure endocrine disruptors (cans or industrial products).
Measured: During the pregnancy (second and third trimester)
Secondary outcomes (4)
psychosocial aspects
Assess if the program impact any psychosocial aspects, this outcome will be determine with a psychosocial questionary (to do before and after the intervention for compare the results)
Measured: During the pregnancy (second and third trimester)
Urine concentration
Assess if the program has an impact on the urinary endocrine disruptors's concentrations, this outcome will be determine with samples of urine (to do before and after the intervention for comparate the results)
Measured: During the pregnancy (second and third trimester)
Milk concentration
Assess the milk endocrine disruptors's concentration difference between women exposed and unexposed to the program
Measured: After the birth of the child (first year)
foetal growth
Study the relation between endocrine disruptors expositions and foetal growth by merging PREVED and EDDS (a previous trial) datas.
Measured: After the birth of the child (first year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start19 Apr 2017
- Primary completion15 May 2019
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233984
- Sponsor's protocol ID
- PREVED
- Status last verified
- Jan 2021
- First submitted
- 26 Jun 2017
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robalo M, Ayraud-Thevenot S, Migeot V, Gourgues AS, Albouy M, Venisse N. Detection of Endocrine Disruptors in Human Placenta: A Pilot Study on Exposure and Histopathological Findings. Ther Drug Monit. 2026 Apr 1;48(2):258-265. doi: 10.1097/FTD.0000000000001414. Epub 2025 Dec 9.
PubMed 41361687Ouazzani HE, Rouillon S, Venisse N, Sifer-Riviere L, Dupuis A, Cambien G, Ayraud-Thevenot S, Gourgues AS, Pierre-Eugene P, Pierre F, Rabouan S; DisProSE Group; Migeot V, Albouy-Llaty M. Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy-PREVED study: study protocol for a randomized controlled trial. Trials. 2021 Dec 4;22(1):876. doi: 10.1186/s13063-021-05813-5.
PubMed 34863252
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention
- ClinicalTrials.gov ID
- NCT03233984
- Acronym / sponsor ID
- PREVED
- Conditions
- Pregnancy, Endocrine System, Prevention Program
- Keywords
- bisphenol-A, prevention, endocrine disruptors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 31 Jul 2017 (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.
Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major foetal pathology and impact growth.
Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and water.
Through a prevention program, the investigators tried to warned pregnant women on endocrine disruptors exposition risks. The goal here is to assess the effectiveness of this program on their fresh products consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leaflet only | No intervention | –Women will only receive a leaflet about endocrine disruptor at home. |
| non immersive program | Active comparator | Behavioral: sensibilisation program "Ma maison, mon environnement santé"In addition of the leaflet, women will sit in the sensibilisation program that will take place in a neutral environment |
| immersive program | Experimental | Behavioral: sensibilisation program "Ma maison, mon environnement santé"In addition of the leaflet, women will si in the sensibilisation program that will take place in an immersive environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18
- Patients living in Poitiers or city around (near the immersive environment)
- Patients on pregnancy and who declared their pregnancy to the authority
- Patients who planned to give birth in Poitiers's hospital, Châtellerault's hospital or Clinique Fief de Grimoire, in Poitiers.
- Patients giving her agreement
Key exclusion criteria (5 listed)
- Patients planning to move during the study
- Patients under legal protection
- Patients expecting twins
- Patients unable to speak french
- Patients willing to give birth in another hospital than those mentionned before
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 |
|---|---|---|
| sensibilisation program "Ma maison, mon environnement santé"The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation. | Behavioural | immersive program, non immersive program |
Primary outcome
program effectivness
Time frame: During the pregnancy (second and third trimester)
Assessing the Effectiveness of the Prevention Program "My Home, My Health Environment" (consists of a series of workshop in the second and third trimesters of pregnancy) in an immersive environment or not, to evaluate the consumption of fresh products according to exposure endocrine disruptors (cans or industrial products).
4 secondary outcomes
psychosocial aspects
Time frame: During the pregnancy (second and third trimester)
Urine concentration
Time frame: During the pregnancy (second and third trimester)
Milk concentration
Time frame: After the birth of the child (first year)
foetal growth
Time frame: After the birth of the child (first year)
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 29 Jan 2021.
- Derived from this study: PubMed 41361687Robalo M, Ayraud-Thevenot S, Migeot V, Gourgues AS, Albouy M, Venisse N. Detection of Endocrine Disruptors in Human Placenta: A Pilot Study on Exposure and Histopathological Findings. Ther Drug Monit. 2026 Apr 1;48(2):258-265. doi: 10.1097/FTD.0000000000001414. Epub 2025 Dec 9.
- Derived from this study: PubMed 34863252Ouazzani HE, Rouillon S, Venisse N, Sifer-Riviere L, Dupuis A, Cambien G, Ayraud-Thevenot S, Gourgues AS, Pierre-Eugene P, Pierre F, Rabouan S; DisProSE Group; Migeot V, Albouy-Llaty M. Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy-PREVED study: study protocol for a randomized controlled trial. Trials. 2021 Dec 4;22(1):876. doi: 10.1186/s13063-021-05813-5.
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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?
A study testing sensibilisation program "Ma maison, mon environnement santé" in people with Pregnancy and Endocrine System, run by Poitiers University Hospital 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 5 inclusion and 5 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 29 Jan 2021. 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?
program effectivness (time frame: During the pregnancy (second and third trimester)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03233984, which also lists 2 linked publications.
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 29 Jan 2021.