Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition

Study Overview
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Brief Summary
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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.

Official Title
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Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention

Conditions
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Pregnancy, Endocrine System, Prevention Program

Intervention / Treatment
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* Behavioral: sensibilisation program Ma maison, mon environnement santé


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Leaflet only<br>Women will only receive a leaflet about endocrine disruptor at home. | |
| Active Comparator: non immersive program<br>In addition of the leaflet, women will sit in the sensibilisation program that will take place in a neutral environment | Behavioral: sensibilisation program Ma maison, mon environnement santé<br>* The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.<br>|
| Experimental: immersive program<br>In addition of the leaflet, women will si in the sensibilisation program that will take place in an immersive environment | Behavioral: sensibilisation program Ma maison, mon environnement santé<br>* The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | During the pregnancy (second and third trimester) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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. | After the birth of the child (first year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bisphenol-A, prevention, endocrine disruptors