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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Endocrine System; Prevention Program
• Intervention / Treatment: Behavioral: sensibilisation program "Ma maison, mon environnement santé"

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Leaflet only; Women will only receive a leaflet about endocrine disruptor at home.
ACTIVE_COMPARATOR: non immersive program; 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"; The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.
EXPERIMENTAL: immersive program; 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"; The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Publications and helpful links

General Publications

• 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. Erratum In: Trials. 2021 Dec 29;22(1):968.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2017
• Primary Completion (ACTUAL): May 15, 2019
• Study Completion (ACTUAL): September 28, 2020

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (ACTUAL): July 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: prevention; endocrine disruptors; bisphenol-A
• Other Study ID Numbers: PREVED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No