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

Not Applicable

Completed

• Conditions: Pregnancy; Prevention Program; Endocrine System
• Interventions: Behavioral: sensibilisation program "Ma maison, mon environnement santé"

• Registration Number: NCT03233984
• Lead Sponsor: Poitiers University Hospital

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-19
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-07-31
• Primary Completion: 2019-05-15
• Study Completion: 2020-09-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 267

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immersive program	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
non immersive program	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

Primary Outcome Measures

Name	Time	Method
program effectivness	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).

Secondary Outcome Measures

Name	Time	Method
psychosocial aspects	During the pregnancy (second and third trimester)	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)
Milk concentration	After the birth of the child (first year)	Assess the milk endocrine disruptors's concentration difference between women exposed and unexposed to the program
Urine concentration	During the pregnancy (second and third trimester)	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)
foetal growth	After the birth of the child (first year)	Study the relation between endocrine disruptors expositions and foetal growth by merging PREVED and EDDS (a previous trial) datas.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, France