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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03233984
Other study ID # PREVED
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 19, 2017
Est. completion date September 28, 2020

Study information

Verified date January 2021
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 267
Est. completion date September 28, 2020
Est. primary completion date May 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Centre Hospitalier Universitaire de Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
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