NCT03233984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

June 26, 2017

Last Update Submit

January 28, 2021

Conditions

PregnancyEndocrine SystemPrevention Program

Keywords

bisphenol-Apreventionendocrine disruptors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • psychosocial aspects

    During the pregnancy (second and third trimester)

  • Urine concentration

    During the pregnancy (second and third trimester)

  • Milk concentration

    After the birth of the child (first year)

  • foetal growth

    After the birth of the child (first year)

Study Arms (3)

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

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

Behavioral: sensibilisation program "Ma maison, mon environnement santé"

Interventions

sensibilisation program "Ma maison, mon environnement santé"BEHAVIORAL

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

immersive programnon immersive program

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Related Publications (2)

  • 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. 2025 Dec 9. doi: 10.1097/FTD.0000000000001414. Online ahead of print.

    PMID: 41361687DERIVED

  • 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.

    PMID: 34863252DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 31, 2017

Study Start

April 19, 2017

Primary Completion

May 15, 2019

Study Completion

September 28, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

FR(1)