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

NCT ID: NCT03233984

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2020-09-28

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.

Detailed Description

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Conditions

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Pregnancy Endocrine System Prevention Program

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Leaflet only

Women will only receive a leaflet about endocrine disruptor at home.

Group Type NO_INTERVENTION

No interventions assigned to this group

non immersive program

In addition of the leaflet, women will sit in the sensibilisation program that will take place in a neutral environment

Group Type ACTIVE_COMPARATOR

sensibilisation program "Ma maison, mon environnement santé"

Intervention Type BEHAVIORAL

The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.

immersive program

In addition of the leaflet, women will si in the sensibilisation program that will take place in an immersive environment

Group Type EXPERIMENTAL

sensibilisation program "Ma maison, mon environnement santé"

Intervention Type BEHAVIORAL

The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.

Interventions

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sensibilisation program "Ma maison, mon environnement santé"

The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Site Status

Countries

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France

References

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Ouazzani 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.

Reference Type DERIVED
PMID: 34863252 (View on PubMed)

Other Identifiers

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PREVED

Identifier Type: -

Identifier Source: org_study_id

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